Surgical devices, systems, and methods using multi-source imaging

ABSTRACT

In general, devices, systems, and methods for multi-source imaging are provided.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Prov. Pat. App. No.63/249,644 entitled “Surgical Devices, Systems, And Methods UsingMulti-Source Imaging” filed Sep. 29, 2021, which is hereby incorporatedby reference in its entirety.

FIELD

The present disclosure relates generally to surgical devices, systems,and methods using multi-source imaging.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowmedical practitioners to view a surgical site and/or one or moreportions thereof on one or more displays, e.g., a monitor, a computertablet screen, etc. The display(s) can be local and/or remote to asurgical theater. The imaging system can include a scope with a camerathat views the surgical site and transmits the view to the one or moredisplays viewable by medical practitioner(s).

Imaging systems can be limited by the information that they are able torecognize and/or convey to the medical practitioner(s). For example,certain concealed structures, physical contours, and/or dimensionswithin a three-dimensional space may be unrecognizable intraoperativelyby certain imaging systems. For another example, certain imaging systemsmay be incapable of communicating and/or conveying certain informationto the medical practitioner(s) intraoperatively.

Accordingly, there remains a need for improved surgical imaging.

SUMMARY

In general, devices, systems, and methods for multi-source imaging areprovided.

In one aspect, a surgical method is provided that in one embodimentincludes visualizing a surgical site with a first visualization system,visualizing the surgical site with a second visualization systemconfigured to visualize the surgical site, and monitoring, with acontroller and during the second visualization system's visualization ofthe surgical site, energy delivery to tissue at the surgical site. Theenergy is being delivered to the tissue by an electrode of a surgicalinstrument positioned in a lumen of the first visualization system. Themethod also includes controlling, with the controller, energizing of theelectrode such that a parameter associated with the tissue does notexceed a predefined maximum threshold.

The method can vary in any number of ways. For example, the predefinedmaximum threshold can include a temperature of the tissue, and themethod can further include measuring the temperature of the tissue witha sensor operatively coupled to the controller. For another example, thepredefined maximum threshold can include a temperature of the tissue,the electrode can include an electrode array, and the method can furtherinclude measuring the temperature of the tissue with the electrodearray. For still another example, the predefined maximum threshold caninclude a surface water content of the tissue, and the method canfurther include measuring the surface water content of the tissue with asensor operatively coupled to the controller. For another example, thepredefined maximum threshold can include a refractivity of the tissue,and the method can further include measuring the refractivity of thetissue with at least one of the first and second visualization systems.For yet another example, the first visualization system can bevisualizing within a hollow organ at the surgical site, the tissue canbe tissue within the hollow organ, and the second visualization systemcan be visualizing outside the hollow organ. For another example, theenergy can include one of radiofrequency (RF) energy and microwaveenergy. For yet another example, the tissue can include a tumor, and theenergy can include cold so as to treat the tumor with cyroablation. Forstill another example, a surgical hub can include the controller. Foryet another example, a robotic surgical system can include thecontroller, and the surgical instrument can be configured to bereleasably coupled to and controlled by the robotic surgical system.

In another aspect, a surgical system is provided that in one embodimentincludes a first visualization system configured to visualize a surgicalsite, and a surgical instrument configured to be advanced to thesurgical site through a lumen of the first visualization system. Thesurgical includes an electrode configured to deliver energy to tissue ata surgical site. The system also includes a second visualization systemconfigured to visualize the surgical site, and a controller configuredto be operatively coupled to the electrosurgical instrument and to thesecond visualization system, monitor the electrode's energy delivery tothe tissue during the delivery and during the second visualizationsystem's visualization of the surgical site, and control energizing ofthe electrode such that a parameter associated with the tissue does notexceed a predefined maximum threshold.

The system can vary in any number of ways. For example, the predefinedmaximum threshold can include a temperature of the tissue, and thesystem can further include a sensor operatively coupled to thecontroller and configured to measure the temperature of the tissue. Foranother example, the predefined maximum threshold includes a temperatureof the tissue, and the electrode can include an electrode arrayconfigured to measure the temperature of the tissue. For yet anotherexample, the predefined maximum threshold can include a surface watercontent of the tissue, and the system can further include a sensoroperatively coupled to the controller and configured to measure thesurface water content of the tissue. For still another example, thepredefined maximum threshold can include a refractivity of the tissue,and at least one of the first and second visualization systems can beconfigured to measure the refractivity of the tissue. For anotherexample, the first visualization system can be configured to visualizewithin a hollow organ at the surgical site, the tissue can be tissuewithin the hollow organ, and the second visualization system can beconfigured to visualize outside the hollow organ. For yet anotherexample, the energy can include one of radiofrequency (RF) energy andmicrowave energy. For still another example, the tissue can include atumor, and the energy can include cold so as to treat the tumor withcyroablation. For another example, a surgical hub can include thecontroller. For still another example, a robotic surgical system caninclude the controller, and the surgical instrument can be configured tobe releasably coupled to and controlled by the robotic surgical system.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is described by way of reference to theaccompanying figures which are as follows:

FIG. 1 is a schematic view of one embodiment of a surgical visualizationsystem;

FIG. 2 is a schematic view of triangularization between a surgicaldevice, an imaging device, and a critical structure of FIG. 1 ;

FIG. 3 is a schematic view of another embodiment of a surgicalvisualization system;

FIG. 4 is a schematic view of one embodiment of a control system for asurgical visualization system;

FIG. 5 is a schematic view of one embodiment of a control circuit of acontrol system for a surgical visualization system;

FIG. 6 is a schematic view of one embodiment of a combinational logiccircuit of a surgical visualization system;

FIG. 7 is a schematic view of one embodiment of a sequential logiccircuit of a surgical visualization system;

FIG. 8 is a schematic view of yet another embodiment of a surgicalvisualization system;

FIG. 9 is a schematic view of another embodiment of a control system fora surgical visualization system;

FIG. 10 is a graph showing wavelength versus absorption coefficient forvarious biological materials;

FIG. 11 is a schematic view of one embodiment of a spectral emittervisualizing a surgical site;

FIG. 12 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate a ureter from obscurants;

FIG. 13 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate an artery from obscurants;

FIG. 14 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate a nerve from obscurants;

FIG. 15 is a schematic view of one embodiment of a near infrared (NIR)time-of-flight measurement system being utilized intraoperatively;

FIG. 16 shows a time-of-flight timing diagram for the system of FIG. 15;

FIG. 17 is a schematic view of another embodiment of a near infrared(NIR) time-of-flight measurement system being utilized intraoperatively;

FIG. 18 is a schematic view of one embodiment of a computer-implementedinteractive surgical system;

FIG. 19 is a schematic view of one embodiment a surgical system beingused to perform a surgical procedure in an operating room;

FIG. 20 is a schematic view of one embodiment of a surgical systemincluding a smart surgical instrument and a surgical hub;

FIG. 21 is a flowchart showing a method of controlling the smartsurgical instrument of FIG. 20 ;

FIG. 22 is a schematic view of a colon illustrating major resections ofthe colon;

FIG. 22A is a perspective partial cross-sectional view of one embodimentof a duodenal mucosal resurfacing procedure;

FIG. 23 is illustrates one embodiment of controlling energy of amicrowave ablation device;

FIG. 24 is a perspective view of a distal portion of one embodiment ofan ablation device in a compressed configuration;

FIG. 25 is a perspective view of the distal portion the ablation deviceof FIG. 24 in an expanded configuration;

FIG. 26 is a perspective view of the ablation device of FIG. 25positioned relative to a tumor;

FIG. 27 is a schematic partially cross-sectional view of one embodimentof a tissue lumen having a flexible scope positioned therein and alaparoscope positioned outside thereof;

FIG. 28 is a schematic cross-sectional view of one embodiment of aflexible force probe pressing on a tissue wall in which a scope ispositioned; and

FIG. 29 is a perspective view of the probe and the scope of FIG. 28 .

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices, systems, and methods disclosedherein. One or more examples of these embodiments are illustrated in theaccompanying drawings. A person skilled in the art will understand thatthe devices, systems, and methods specifically described herein andillustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. A person skilled inthe art will appreciate that a dimension or other measurement may not bea precise value but nevertheless be considered to be at about that valuedue to any number of factors such as manufacturing tolerances andsensitivity of measurement equipment. Sizes and shapes of the systemsand devices, and the components thereof, can depend at least on the sizeand shape of components with which the systems and devices will be used.

Surgical Visualization

In general, a surgical visualization system is configured to leverage“digital surgery” to obtain additional information about a patient'sanatomy and/or a surgical procedure. The surgical visualization systemis further configured to convey data to one or more medicalpractitioners in a helpful manner. Various aspects of the presentdisclosure provide improved visualization of the patient's anatomyand/or the surgical procedure, and/or use visualization to provideimproved control of a surgical tool (also referred to herein as a“surgical device” or a “surgical instrument”).

“Digital surgery” can embrace robotic systems, advanced imaging,advanced instrumentation, artificial intelligence, machine learning,data analytics for performance tracking and benchmarking, connectivityboth inside and outside of the operating room (OR), and more. Althoughvarious surgical visualization systems described herein can be used incombination with a robotic surgical system, surgical visualizationsystems are not limited to use with a robotic surgical system. Incertain instances, surgical visualization using a surgical visualizationsystem can occur without robotics and/or with limited and/or optionalrobotic assistance. Similarly, digital surgery can occur withoutrobotics and/or with limited and/or optional robotic assistance.

In certain instances, a surgical system that incorporates a surgicalvisualization system may enable smart dissection in order to identifyand avoid critical structures. Critical structures include anatomicalstructures such as a ureter, an artery such as a superior mesentericartery, a vein such as a portal vein, a nerve such as a phrenic nerve,and/or a tumor, among other anatomical structures. In other instances, acritical structure can be a foreign structure in the anatomical field,such as a surgical device, a surgical fastener, a clip, a tack, abougie, a band, a plate, and other foreign structures. Criticalstructures can be determined on a patient-by-patient and/or aprocedure-by-procedure basis. Smart dissection technology may provide,for example, improved intraoperative guidance for dissection and/or mayenable smarter decisions with critical anatomy detection and avoidancetechnology.

A surgical system incorporating a surgical visualization system mayenable smart anastomosis technologies that provide more consistentanastomoses at optimal location(s) with improved workflow. Cancerlocalization technologies may be improved with a surgical visualizationplatform. For example, cancer localization technologies can identify andtrack a cancer location, orientation, and its margins. In certaininstances, the cancer localization technologies may compensate formovement of a surgical instrument, a patient, and/or the patient'sanatomy during a surgical procedure in order to provide guidance back tothe point of interest for medical practitioner(s).

A surgical visualization system may provide improved tissuecharacterization and/or lymph node diagnostics and mapping. For example,tissue characterization technologies may characterize tissue type andhealth without the need for physical haptics, especially when dissectingand/or placing stapling devices within the tissue. Certain tissuecharacterization technologies may be utilized without ionizing radiationand/or contrast agents. With respect to lymph node diagnostics andmapping, a surgical visualization platform may, for example,preoperatively locate, map, and ideally diagnose the lymph system and/orlymph nodes involved in cancerous diagnosis and staging.

During a surgical procedure, information available to a medicalpractitioner via the “naked eye” and/or an imaging system may provide anincomplete view of the surgical site. For example, certain structures,such as structures embedded or buried within an organ, can be at leastpartially concealed or hidden from view. Additionally, certaindimensions and/or relative distances can be difficult to ascertain withexisting sensor systems and/or difficult for the “naked eye” toperceive. Moreover, certain structures can move pre-operatively (e.g.,before a surgical procedure but after a preoperative scan) and/orintraoperatively. In such instances, the medical practitioner can beunable to accurately determine the location of a critical structureintraoperatively.

When the position of a critical structure is uncertain and/or when theproximity between the critical structure and a surgical tool is unknown,a medical practitioner's decision-making process can be inhibited. Forexample, a medical practitioner may avoid certain areas in order toavoid inadvertent dissection of a critical structure; however, theavoided area may be unnecessarily large and/or at least partiallymisplaced. Due to uncertainty and/or overly/excessive exercises incaution, the medical practitioner may not access certain desiredregions. For example, excess caution may cause a medical practitioner toleave a portion of a tumor and/or other undesirable tissue in an effortto avoid a critical structure even if the critical structure is not inthe particular area and/or would not be negatively impacted by themedical practitioner working in that particular area. In certaininstances, surgical results can be improved with increased knowledgeand/or certainty, which can allow a surgeon to be more accurate and, incertain instances, less conservative/more aggressive with respect toparticular anatomical areas.

A surgical visualization system can allow for intraoperativeidentification and avoidance of critical structures. The surgicalvisualization system may thus enable enhanced intraoperative decisionmaking and improved surgical outcomes. The surgical visualization systemcan provide advanced visualization capabilities beyond what a medicalpractitioner sees with the “naked eye” and/or beyond what an imagingsystem can recognize and/or convey to the medical practitioner. Thesurgical visualization system can augment and enhance what a medicalpractitioner is able to know prior to tissue treatment (e.g.,dissection, etc.) and, thus, may improve outcomes in various instances.As a result, the medical practitioner can confidently maintain momentumthroughout the surgical procedure knowing that the surgicalvisualization system is tracking a critical structure, which may beapproached during dissection, for example. The surgical visualizationsystem can provide an indication to the medical practitioner insufficient time for the medical practitioner to pause and/or slow downthe surgical procedure and evaluate the proximity to the criticalstructure to prevent inadvertent damage thereto. The surgicalvisualization system can provide an ideal, optimized, and/orcustomizable amount of information to the medical practitioner to allowthe medical practitioner to move confidently and/or quickly throughtissue while avoiding inadvertent damage to healthy tissue and/orcritical structure(s) and, thus, to minimize the risk of harm resultingfrom the surgical procedure.

Surgical visualization systems are described in detail below. Ingeneral, a surgical visualization system can include a first lightemitter configured to emit a plurality of spectral waves, a second lightemitter configured to emit a light pattern, and a receiver, or sensor,configured to detect visible light, molecular responses to the spectralwaves (spectral imaging), and/or the light pattern. The surgicalvisualization system can also include an imaging system and a controlcircuit in signal communication with the receiver and the imagingsystem. Based on output from the receiver, the control circuit candetermine a geometric surface map, e.g., three-dimensional surfacetopography, of the visible surfaces at the surgical site and a distancewith respect to the surgical site, such as a distance to an at leastpartially concealed structure. The imaging system can convey thegeometric surface map and the distance to a medical practitioner. Insuch instances, an augmented view of the surgical site provided to themedical practitioner can provide a representation of the concealedstructure within the relevant context of the surgical site. For example,the imaging system can virtually augment the concealed structure on thegeometric surface map of the concealing and/or obstructing tissuesimilar to a line drawn on the ground to indicate a utility line belowthe surface. Additionally or alternatively, the imaging system canconvey the proximity of a surgical tool to the visible and obstructingtissue and/or to the at least partially concealed structure and/or adepth of the concealed structure below the visible surface of theobstructing tissue. For example, the visualization system can determinea distance with respect to the augmented line on the surface of thevisible tissue and convey the distance to the imaging system.

Throughout the present disclosure, any reference to “light,” unlessspecifically in reference to visible light, can include electromagneticradiation (EMR) or photons in the visible and/or non-visible portions ofthe EMR wavelength spectrum. The visible spectrum, sometimes referred toas the optical spectrum or luminous spectrum, is that portion of theelectromagnetic spectrum that is visible to (e.g., can be detected by)the human eye and may be referred to as “visible light” or simply“light.” A typical human eye will respond to wavelengths in air that arefrom about 380 nm to about 750 nm. The invisible spectrum (e.g., thenon-luminous spectrum) is that portion of the electromagnetic spectrumthat lies below and above the visible spectrum. The invisible spectrumis not detectable by the human eye. Wavelengths greater than about 750nm are longer than the red visible spectrum, and they become invisibleinfrared (IR), microwave, and radio electromagnetic radiation.Wavelengths less than about 380 nm are shorter than the violet spectrum,and they become invisible ultraviolet, x-ray, and gamma rayelectromagnetic radiation.

FIG. 1 illustrates one embodiment of a surgical visualization system100. The surgical visualization system 100 is configured to create avisual representation of a critical structure 101 within an anatomicalfield. The critical structure 101 can include a single criticalstructure or a plurality of critical structures. As discussed herein,the critical structure 101 can be any of a variety of structures, suchas an anatomical structure, e.g., a ureter, an artery such as a superiormesenteric artery, a vein such as a portal vein, a nerve such as aphrenic nerve, a vessel, a tumor, or other anatomical structure, or aforeign structure, e.g., a surgical device, a surgical fastener, asurgical clip, a surgical tack, a bougie, a surgical band, a surgicalplate, or other foreign structure. As discussed herein, the criticalstructure 101 can be identified on a patient-by-patient and/or aprocedure-by-procedure basis. Embodiments of critical structures and ofidentifying critical structures using a visualization system are furtherdescribed in U.S. Pat. No. 10,792,034 entitled “Visualization OfSurgical Devices” issued Oct. 6, 2020, which is hereby incorporated byreference in its entirety.

In some instances, the critical structure 101 can be embedded in tissue103. The tissue 103 can be any of a variety of tissues, such as fat,connective tissue, adhesions, and/or organs. Stated differently, thecritical structure 101 may be positioned below a surface 105 of thetissue 103. In such instances, the tissue 103 conceals the criticalstructure 101 from the medical practitioner's “naked eye” view. Thetissue 103 also obscures the critical structure 101 from the view of animaging device 120 of the surgical visualization system 100. Instead ofbeing fully obscured, the critical structure 101 can be partiallyobscured from the view of the medical practitioner and/or the imagingdevice 120.

The surgical visualization system 100 can be used for clinical analysisand/or medical intervention. In certain instances, the surgicalvisualization system 100 can be used intraoperatively to providereal-time information to the medical practitioner during a surgicalprocedure, such as real-time information regarding proximity data,dimensions, and/or distances. A person skilled in the art willappreciate that information may not be precisely real time butnevertheless be considered to be real time for any of a variety ofreasons, such as time delay induced by data transmission, time delayinduced by data processing, and/or sensitivity of measurement equipment.The surgical visualization system 100 is configured for intraoperativeidentification of critical structure(s) and/or to facilitate theavoidance of the critical structure(s) 101 by a surgical device. Forexample, by identifying the critical structure 101, a medicalpractitioner can avoid maneuvering a surgical device around the criticalstructure 101 and/or a region in a predefined proximity of the criticalstructure 101 during a surgical procedure. For another example, byidentifying the critical structure 101, a medical practitioner can avoiddissection of and/or near the critical structure 101, thereby helping toprevent damage to the critical structure 101 and/or helping to prevent asurgical device being used by the medical practitioner from beingdamaged by the critical structure 101.

The surgical visualization system 100 is configured to incorporatetissue identification and geometric surface mapping in combination withthe surgical visualization system's distance sensor system 104. Incombination, these features of the surgical visualization system 100 candetermine a position of a critical structure 101 within the anatomicalfield and/or the proximity of a surgical device 102 to the surface 105of visible tissue 103 and/or to the critical structure 101. Moreover,the surgical visualization system 100 includes an imaging system thatincludes the imaging device 120 configured to provide real-time views ofthe surgical site. The imaging device 120 can include, for example, aspectral camera (e.g., a hyperspectral camera, multispectral camera, orselective spectral camera), which is configured to detect reflectedspectral waveforms and generate a spectral cube of images based on themolecular response to the different wavelengths. Views from the imagingdevice 120 can be provided in real time to a medical practitioner, suchas on a display (e.g., a monitor, a computer tablet screen, etc.). Thedisplayed views can be augmented with additional information based onthe tissue identification, landscape mapping, and the distance sensorsystem 104. In such instances, the surgical visualization system 100includes a plurality of subsystems—an imaging subsystem, a surfacemapping subsystem, a tissue identification subsystem, and/or a distancedetermining subsystem. These subsystems can cooperate tointra-operatively provide advanced data synthesis and integratedinformation to the medical practitioner.

The imaging device 120 can be configured to detect visible light,spectral light waves (visible or invisible), and a structured lightpattern (visible or invisible). Examples of the imaging device 120includes scopes, e.g., an endoscope, an arthroscope, an angioscope, abronchoscope, a choledochoscope, a colonoscope, a cytoscope, aduodenoscope, an enteroscope, an esophagogastro-duodenoscope(gastroscope), a laryngoscope, a nasopharyngo-neproscope, asigmoidoscope, a thoracoscope, an ureteroscope, or an exoscope. Scopescan be particularly useful in minimally invasive surgical procedures. Inopen surgery applications, the imaging device 120 may not include ascope.

The tissue identification subsystem can be achieved with a spectralimaging system. The spectral imaging system can rely on imaging such ashyperspectral imaging, multispectral imaging, or selective spectralimaging. Embodiments of hyperspectral imaging of tissue are furtherdescribed in U.S. Pat. No. 9,274,047 entitled “System And Method ForGross Anatomic Pathology Using Hyperspectral Imaging” issued Mar. 1,2016, which is hereby incorporated by reference in its entirety.

The surface mapping subsystem can be achieved with a light patternsystem. Various surface mapping techniques using a light pattern (orstructured light) for surface mapping can be utilized in the surgicalvisualization systems described herein. Structured light is the processof projecting a known pattern (often a grid or horizontal bars) on to asurface. In certain instances, invisible (or imperceptible) structuredlight can be utilized, in which the structured light is used withoutinterfering with other computer vision tasks for which the projectedpattern may be confusing. For example, infrared light or extremely fastframe rates of visible light that alternate between two exact oppositepatterns can be utilized to prevent interference. Embodiments of surfacemapping and a surgical system including a light source and a projectorfor projecting a light pattern are further described in U.S. Pat. Pub.No. 2017/0055819 entitled “Set Comprising A Surgical Instrument”published Mar. 2, 2017, U.S. Pat. Pub. No. 2017/0251900 entitled“Depiction System” published Sep. 7, 2017, and U.S. Pat. Pub. No.2021/0196385 entitled “Surgical Systems For Generating Three DimensionalConstructs Of Anatomical Organs And Coupling Identified AnatomicalStructures Thereto” published Jul. 1, 2021, which are herebyincorporated by reference in their entireties.

The distance determining system can be incorporated into the surfacemapping system. For example, structured light can be utilized togenerate a three-dimensional (3D) virtual model of the visible surface105 and determine various distances with respect to the visible surface105. Additionally or alternatively, the distance determining system canrely on time-of-flight measurements to determine one or more distancesto the identified tissue (or other structures) at the surgical site.

The surgical visualization system 100 also includes a surgical device102. The surgical device 102 can be any suitable surgical device.Examples of the surgical device 102 includes a surgical dissector, asurgical stapler, a surgical grasper, a clip applier, a smoke evacuator,a surgical energy device (e.g., mono-polar probes, bi-polar probes,ablation probes, an ultrasound device, an ultrasonic end effector,etc.), etc. In some embodiments, the surgical device 102 includes an endeffector having opposing jaws that extend from a distal end of a shaftof the surgical device 102 and that are configured to engage tissuetherebetween.

The surgical visualization system 100 can be configured to identify thecritical structure 101 and a proximity of the surgical device 102 to thecritical structure 101. The imaging device 120 of the surgicalvisualization system 100 is configured to detect light at variouswavelengths, such as visible light, spectral light waves (visible orinvisible), and a structured light pattern (visible or invisible). Theimaging device 120 can include a plurality of lenses, sensors, and/orreceivers for detecting the different signals. For example, the imagingdevice 120 can be a hyperspectral, multispectral, or selective spectralcamera, as described herein. The imaging device 120 can include awaveform sensor 122 (such as a spectral image sensor, detector, and/orthree-dimensional camera lens). For example, the imaging device 120 caninclude a right-side lens and a left-side lens used together to recordtwo two-dimensional images at the same time and, thus, generate a 3Dimage of the surgical site, render a three-dimensional image of thesurgical site, and/or determine one or more distances at the surgicalsite. Additionally or alternatively, the imaging device 120 can beconfigured to receive images indicative of the topography of the visibletissue and the identification and position of hidden criticalstructures, as further described herein. For example, a field of view ofthe imaging device 120 can overlap with a pattern of light (structuredlight) on the surface 105 of the tissue 103, as shown in FIG. 1 .

As in this illustrated embodiment, the surgical visualization system 100can be incorporated into a robotic surgical system 110. The roboticsurgical system 110 can have a variety of configurations, as discussedherein. In this illustrated embodiment, the robotic surgical system 110includes a first robotic arm 112 and a second robotic arm 114. Therobotic arms 112, 114 each include rigid structural members 116 andjoints 118, which can include servomotor controls. The first robotic arm112 is configured to maneuver the surgical device 102, and the secondrobotic arm 114 is configured to maneuver the imaging device 120. Arobotic control unit of the robotic surgical system 110 is configured toissue control motions to the first and second robotic arms 112, 114,which can affect the surgical device 102 and the imaging device 120,respectively.

In some embodiments, one or more of the robotic arms 112, 114 can beseparate from the main robotic system 110 used in the surgicalprocedure. For example, at least one of the robotic arms 112, 114 can bepositioned and registered to a particular coordinate system without aservomotor control. For example, a closed-loop control system and/or aplurality of sensors for the robotic arms 112, 114 can control and/orregister the position of the robotic arm(s) 112, 114 relative to theparticular coordinate system. Similarly, the position of the surgicaldevice 102 and the imaging device 120 can be registered relative to aparticular coordinate system.

Examples of robotic surgical systems include the Ottava™robotic-assisted surgery system (Johnson & Johnson of New Brunswick,N.J.), da Vinci® surgical systems (Intuitive Surgical, Inc. ofSunnyvale, Calif.), the Hugo™ robotic-assisted surgery system (MedtronicPLC of Minneapolis, Minn.), the Versius® surgical robotic system (CMRSurgical Ltd of Cambridge, UK), and the Monarch® platform (Auris Health,Inc. of Redwood City, Calif.). Embodiments of various robotic surgicalsystems and using robotic surgical systems are further described in U.S.Pat. Pub. No. 2018/0177556 entitled “Flexible Instrument Insertion UsingAn Adaptive Force Threshold” filed Dec. 28, 2016, U.S. Pat. Pub. No.2020/0000530 entitled “Systems And Techniques For Providing MultiplePerspectives During Medical Procedures” filed Apr. 16, 2019, U.S. Pat.Pub. No. 2020/0170720 entitled “Image-Based Branch Detection And MappingFor Navigation” filed Feb. 7, 2020, U.S. Pat. Pub. No. 2020/0188043entitled “Surgical Robotics System” filed Dec. 9, 2019, U.S. Pat. Pub.No. 2020/0085516 entitled “Systems And Methods For Concomitant MedicalProcedures” filed Sep. 3, 2019, U.S. Pat. No. 8,831,782 entitled“Patient-Side Surgeon Interface For A Teleoperated Surgical Instrument”filed Jul. 15, 2013, and Intl. Pat. Pub. No. WO 2014151621 entitled“Hyperdexterous Surgical System” filed Mar. 13, 2014, which are herebyincorporated by reference in their entireties.

The surgical visualization system 100 also includes an emitter 106. Theemitter 106 is configured to emit a pattern of light, such as stripes,grid lines, and/or dots, to enable the determination of the topographyor landscape of the surface 105. For example, projected light arrays 130can be used for three-dimensional scanning and registration on thesurface 105. The projected light arrays 130 can be emitted from theemitter 106 located on the surgical device 102 and/or one of the roboticarms 112, 114 and/or the imaging device 120. In one aspect, theprojected light array 130 is employed by the surgical visualizationsystem 100 to determine the shape defined by the surface 105 of thetissue 103 and/or motion of the surface 105 intraoperatively. Theimaging device 120 is configured to detect the projected light arrays130 reflected from the surface 105 to determine the topography of thesurface 105 and various distances with respect to the surface 105.

As in this illustrated embodiment, the imaging device 120 can include anoptical waveform emitter 123, such as by being mounted on or otherwiseattached on the imaging device 120. The optical waveform emitter 123 isconfigured to emit electromagnetic radiation 124 (near-infrared (NIR)photons) that can penetrate the surface 105 of the tissue 103 and reachthe critical structure 101. The imaging device 120 and the opticalwaveform emitter 123 can be positionable by the robotic arm 114. Theoptical waveform emitter 123 is mounted on or otherwise on the imagingdevice 120 but in other embodiments can be positioned on a separatesurgical device from the imaging device 120. A corresponding waveformsensor 122 (e.g., an image sensor, spectrometer, or vibrational sensor)of the imaging device 120 is configured to detect the effect of theelectromagnetic radiation received by the waveform sensor 122. Thewavelengths of the electromagnetic radiation 124 emitted by the opticalwaveform emitter 123 are configured to enable the identification of thetype of anatomical and/or physical structure, such as the criticalstructure 101. The identification of the critical structure 101 can beaccomplished through spectral analysis, photo-acoustics, and/orultrasound, for example. In one aspect, the wavelengths of theelectromagnetic radiation 124 can be variable. The waveform sensor 122and optical waveform emitter 123 can be inclusive of a multispectralimaging system and/or a selective spectral imaging system, for example.In other instances, the waveform sensor 122 and optical waveform emitter123 can be inclusive of a photoacoustic imaging system, for example.

The distance sensor system 104 of the surgical visualization system 100is configured to determine one or more distances at the surgical site.The distance sensor system 104 can be a time-of-flight distance sensorsystem that includes an emitter, such as the emitter 106 as in thisillustrated embodiment, and that includes a receiver 108. In otherinstances, the time-of-flight emitter can be separate from thestructured light emitter. The emitter 106 can include a very tiny lasersource, and the receiver 108 can include a matching sensor. The distancesensor system 104 is configured to detect the “time of flight,” or howlong the laser light emitted by the emitter 106 has taken to bounce backto the sensor portion of the receiver 108. Use of a very narrow lightsource in the emitter 106 enables the distance sensor system 104 todetermining the distance to the surface 105 of the tissue 103 directlyin front of the distance sensor system 104.

The receiver 108 of the distance sensor system 104 is positioned on thesurgical device 102 in this illustrated embodiment, but in otherembodiments the receiver 108 can be mounted on a separate surgicaldevice instead of the surgical device 102. For example, the receiver 108can be mounted on a cannula or trocar through which the surgical device102 extends to reach the surgical site. In still other embodiments, thereceiver 108 for the distance sensor system 104 can be mounted on aseparate robotically-controlled arm of the robotic system 110 (e.g., onthe second robotic arm 114) than the first robotic arm 112 to which thesurgical device 102 is coupled, can be mounted on a movable arm that isoperated by another robot, or be mounted to an operating room (OR) tableor fixture. In some embodiments, the imaging device 120 includes thereceiver 108 to allow for determining the distance from the emitter 106to the surface 105 of the tissue 103 using a line between the emitter106 on the surgical device 102 and the imaging device 120. For example,a distance d_(e) can be triangulated based on known positions of theemitter 106 (on the surgical device 102) and the receiver 108 (on theimaging device 120) of the distance sensor system 104. The 3D positionof the receiver 108 can be known and/or registered to the robotcoordinate plane intraoperatively.

As in this illustrated embodiment, the position of the emitter 106 ofthe distance sensor system 104 can be controlled by the first roboticarm 112, and the position of the receiver 108 of the distance sensorsystem 104 can be controlled by the second robotic arm 114. In otherembodiments, the surgical visualization system 100 can be utilized apartfrom a robotic system. In such instances, the distance sensor system 104can be independent of the robotic system.

In FIG. 1 , distance d_(e) is emitter-to-tissue distance from theemitter 106 to the surface 105 of the tissue 103, and distance d_(t) isdevice-to-tissue distance from a distal end of the surgical device 102to the surface 105 of the tissue 103. The distance sensor system 104 isconfigured to determine the emitter-to-tissue distance d_(e). Thedevice-to-tissue distance d_(t) is obtainable from the known position ofthe emitter 106 on the surgical device 102, e.g., on a shaft thereofproximal to the surgical device's distal end, relative to the distal endof the surgical device 102. In other words, when the distance betweenthe emitter 106 and the distal end of the surgical device 102 is known,the device-to-tissue distance d_(t) can be determined from theemitter-to-tissue distance d_(e). In some embodiments, the shaft of thesurgical device 102 can include one or more articulation joints and canbe articulatable with respect to the emitter 106 and jaws at the distalend of the surgical device 102. The articulation configuration caninclude a multi joint vertebrae-like structure, for example. In someembodiments, a 3D camera can be utilized to triangulate one or moredistances to the surface 105.

In FIG. 1 , distance d_(w) is camera-to-critical structure distance fromthe optical waveform emitter 123 located on the imaging device 120 tothe surface of the critical structure 101, and distance d_(A) is a depthof the critical structure 101 below the surface 105 of the tissue 103(e.g., the distance between the portion of the surface 105 closest tothe surgical device 102 and the critical structure 101). Thetime-of-flight of the optical waveforms emitted from the opticalwaveform emitter 123 located on the imaging device 120 are configured todetermine the camera-to-critical structure distance d_(w).

As shown in FIG. 2 , the depth d_(A) of the critical structure 101relative to the surface 105 of the tissue 103 can be determined bytriangulating from the camera-to-critical structure distance d_(w) andknown positions of the emitter 106 on the surgical device 102 and theoptical waveform emitter 123 on the imaging device 120 (and, thus, theknown distance d_(x) therebetween) to determine distance d_(y), which isthe sum of the distances d_(e) and d_(A). Additionally or alternatively,time-of-flight from the optical waveform emitter 123 can be configuredto determine the distance from the optical waveform emitter 123 to thesurface 105 of the tissue 103. For example, a first waveform (or rangeof waveforms) can be utilized to determine the camera-to-criticalstructure distance d_(w) and a second waveform (or range of waveforms)can be utilized to determine the distance to the surface 105 of thetissue 103. In such instances, the different waveforms can be utilizedto determine the depth of the critical structure 101 below the surface105 of the tissue 103.

Additionally or alternatively, the distance d_(A) can be determined froman ultrasound, a registered magnetic resonance imaging (MRI), orcomputerized tomography (CT) scan. In still other instances, thedistance d_(A) can be determined with spectral imaging because thedetection signal received by the imaging device 120 can vary based onthe type of material, e.g., type of the tissue 103. For example, fat candecrease the detection signal in a first way, or a first amount, andcollagen can decrease the detection signal in a different, second way,or a second amount.

In another embodiment of a surgical visualization system 160 illustratedin FIG. 3 , a surgical device 162, and not the imaging device 120,includes the optical waveform emitter 123 and the waveform sensor 122that is configured to detect the reflected waveforms. The opticalwaveform emitter 123 is configured to emit waveforms for determining thedistances d_(t) and d_(w) from a common device, such as the surgicaldevice 162, as described herein. In such instances, the distance d_(A)from the surface 105 of the tissue 103 to the surface of the criticalstructure 101 can be determined as follows:

d _(A) =d _(w) −d _(t)

The surgical visualization system 100 includes a control systemconfigured to control various aspects of the surgical visualizationsystem 100. FIG. 4 illustrates one embodiment of a control system 133that can be utilized as the control system of the surgical visualizationsystem 100 (or other surgical visualization system described herein).The control system 133 includes a control circuit 132 configured to bein signal communication with a memory 134. The memory 134 is configuredto store instructions executable by the control circuit 132, such asinstructions to determine and/or recognize critical structures (e.g.,the critical structure 101 of FIG. 1 ), instructions to determine and/orcompute one or more distances and/or three-dimensional digitalrepresentations, and instructions to communicate information to amedical practitioner. As in this illustrated embodiment, the memory 134can store surface mapping logic 136, imaging logic 138, tissueidentification logic 140, and distance determining logic 141, althoughthe memory 134 can store any combinations of the logics 136, 138, 140,141 and/or can combine various logics together. The control system 133also includes an imaging system 142 including a camera 144 (e.g., theimaging system including the imaging device 120 of FIG. 1 ), a display146 (e.g., a monitor, a computer tablet screen, etc.), and controls 148of the camera 144 and the display 146. The camera 144 includes an imagesensor 135 (e.g., the waveform sensor 122) configured to receive signalsfrom various light sources emitting light at various visible andinvisible spectra (e.g., visible light, spectral imagers,three-dimensional lens, etc.). The display 146 is configured to depictreal, virtual, and/or virtually-augmented images and/or information to amedical practitioner.

In an exemplary embodiment, the image sensor 135 is a solid-stateelectronic device containing up to millions of discrete photodetectorsites called pixels. The image sensor 135 technology falls into one oftwo categories: Charge-Coupled Device (CCD) and Complementary MetalOxide Semiconductor (CMOS) imagers and more recently, short-waveinfrared (SWIR) is an emerging technology in imaging. Another type ofthe image sensor 135 employs a hybrid CCD/CMOS architecture (sold underthe name “sCMOS”) and consists of CMOS readout integrated circuits(ROICs) that are bump bonded to a CCD imaging substrate. CCD and CMOSimage sensors are sensitive to wavelengths in a range of about 350 nm toabout 1050 nm, such as in a range of about 400 nm to about 1000 nm. Aperson skilled in the art will appreciate that a value may not beprecisely at a value but nevertheless considered to be about that valuefor any of a variety of reasons, such as sensitivity of measurementequipment and manufacturing tolerances. CMOS sensors are, in general,more sensitive to IR wavelengths than CCD sensors. Solid state imagesensors are based on the photoelectric effect and, as a result, cannotdistinguish between colors. Accordingly, there are two types of colorCCD cameras: single chip and three-chip. Single chip color CCD camerasoffer a common, low-cost imaging solution and use a mosaic (e.g., Bayer)optical filter to separate incoming light into a series of colors andemploy an interpolation algorithm to resolve full color images. Eachcolor is, then, directed to a different set of pixels. Three-chip colorCCD cameras provide higher resolution by employing a prism to directeach section of the incident spectrum to a different chip. More accuratecolor reproduction is possible, as each point in space of the object hasseparate RGB intensity values, rather than using an algorithm todetermine the color. Three-chip cameras offer extremely highresolutions.

The control system 133 also includes an emitter (e.g., the emitter 106)including a spectral light source 150 and a structured light source 152each operably coupled to the control circuit 133. A single source can bepulsed to emit wavelengths of light in the spectral light source 150range and wavelengths of light in the structured light source 152 range.Alternatively, a single light source can be pulsed to provide light inthe invisible spectrum (e.g., infrared spectral light) and wavelengthsof light on the visible spectrum. The spectral light source 150 can be,for example, a hyperspectral light source, a multispectral light source,and/or a selective spectral light source. The tissue identificationlogic 140 is configured to identify critical structure(s) (e.g., thecritical structure 101 of FIG. 1 ) via data from the spectral lightsource 150 received by the image sensor 135 of the camera 144. Thesurface mapping logic 136 is configured to determine the surfacecontours of the visible tissue (e.g., the tissue 103) based on reflectedstructured light. With time-of-flight measurements, the distancedetermining logic 141 is configured to determine one or more distance(s)to the visible tissue and/or the critical structure. Output from each ofthe surface mapping logic 136, the tissue identification logic 140, andthe distance determining logic 141 is configured to be provided to theimaging logic 138, and combined, blended, and/or overlaid by the imaginglogic 138 to be conveyed to a medical practitioner via the display 146of the imaging system 142.

The control circuit 132 can have a variety of configurations. FIG. 5illustrates one embodiment of a control circuit 170 that can be used asthe control circuit 132 configured to control aspects of the surgicalvisualization system 100. The control circuit 170 is configured toimplement various processes described herein. The control circuit 170includes a microcontroller that includes a processor 172 (e.g., amicroprocessor or microcontroller) operably coupled to a memory 174. Thememory 174 is configured to store machine-executable instructions that,when executed by the processor 172, cause the processor 172 to executemachine instructions to implement various processes described herein.The processor 172 can be any one of a number of single-core or multicoreprocessors known in the art. The memory 174 can include volatile andnon-volatile storage media. The processor 172 includes an instructionprocessing unit 176 and an arithmetic unit 178. The instructionprocessing unit 176 is configured to receive instructions from thememory 174.

The surface mapping logic 136, the imaging logic 138, the tissueidentification logic 140, and the distance determining logic 141 canhave a variety of configurations. FIG. 6 illustrates one embodiment of acombinational logic circuit 180 configured to control aspects of thesurgical visualization system 100 using logic such as one or more of thesurface mapping logic 136, the imaging logic 138, the tissueidentification logic 140, and the distance determining logic 141. Thecombinational logic circuit 180 includes a finite state machine thatincludes a combinational logic 182 configured to receive data associatedwith a surgical device (e.g. the surgical device 102 and/or the imagingdevice 120) at an input 184, process the data by the combinational logic182, and provide an output 184 to a control circuit (e.g., the controlcircuit 132).

FIG. 7 illustrates one embodiment of a sequential logic circuit 190configured to control aspects of the surgical visualization system 100using logic such as one or more of the surface mapping logic 136, theimaging logic 138, the tissue identification logic 140, and the distancedetermining logic 141. The sequential logic circuit 190 includes afinite state machine that includes a combinational logic 192, a memory194, and a clock 196. The memory 194 is configured to store a currentstate of the finite state machine. The sequential logic circuit 190 canbe synchronous or asynchronous. The combinational logic 192 isconfigured to receive data associated with a surgical device (e.g. thesurgical device 102 and/or the imaging device 120) at an input 426,process the data by the combinational logic 192, and provide an output499 to a control circuit (e.g., the control circuit 132). In someembodiments, the sequential logic circuit 190 can include a combinationof a processor (e.g., processor 172 of FIG. 5 ) and a finite statemachine to implement various processes herein. In some embodiments, thefinite state machine can include a combination of a combinational logiccircuit (e.g., the combinational logic circuit 192 of FIG. 7 ) and thesequential logic circuit 190.

FIG. 8 illustrates another embodiment of a surgical visualization system200. The surgical visualization system 200 is generally configured andused similar to the surgical visualization system 100 of FIG. 1 , e.g.,includes a surgical device 202 and an imaging device 220. The imagingdevice 220 includes a spectral light emitter 223 configured to emitspectral light in a plurality of wavelengths to obtain a spectral imageof hidden structures, for example. The imaging device 220 can alsoinclude a three-dimensional camera and associated electronic processingcircuits. The surgical visualization system 200 is shown being utilizedintraoperatively to identify and facilitate avoidance of certaincritical structures, such as a ureter 201 a and vessels 201 b, in anorgan 203 (a uterus in this embodiment) that are not visible on asurface 205 of the organ 203.

The surgical visualization system 200 is configured to determine anemitter-to-tissue distance d_(e) from an emitter 206 on the surgicaldevice 202 to the surface 205 of the uterus 203 via structured light.The surgical visualization system 200 is configured to extrapolate adevice-to-tissue distance d_(t) from the surgical device 202 to thesurface 205 of the uterus 203 based on the emitter-to-tissue distanced_(e). The surgical visualization system 200 is also configured todetermine a tissue-to-ureter distance d_(A) from the ureter 201 a to thesurface 205 and a camera-to ureter distance d_(w) from the imagingdevice 220 to the ureter 201 a. As described herein, e.g., with respectto the surgical visualization system 100 of FIG. 1 , the surgicalvisualization system 200 is configured to determine the distance d_(w)with spectral imaging and time-of-flight sensors, for example. Invarious embodiments, the surgical visualization system 200 can determine(e.g., triangulate) the tissue-to-ureter distance d_(A) (or depth) basedon other distances and/or the surface mapping logic described herein.

As mentioned above, a surgical visualization system includes a controlsystem configured to control various aspects of the surgicalvisualization system. The control system can have a variety ofconfigurations. FIG. 9 illustrates one embodiment of a control system600 for a surgical visualization system, such as the surgicalvisualization system 100 of FIG. 1 , the surgical visualization system200 of FIG. 8 , or other surgical visualization system described herein.The control system 600 is a conversion system that integrates spectralsignature tissue identification and structured light tissue positioningto identify a critical structure, especially when those structure(s) areobscured by tissue, e.g., by fat, connective tissue, blood tissue,and/or organ(s), and/or by blood, and/or to detect tissue variability,such as differentiating tumors and/or non-healthy tissue from healthytissue within an organ.

The control system 600 is configured for implementing a hyperspectralimaging and visualization system in which a molecular response isutilized to detect and identify anatomy in a surgical field of view. Thecontrol system 600 includes a conversion logic circuit 648 configured toconvert tissue data to usable information for surgeons and/or othermedical practitioners. For example, variable reflectance based onwavelengths with respect to obscuring material can be utilized toidentify the critical structure in the anatomy. Moreover, the controlsystem 600 is configured to combine the identified spectral signatureand the structural light data in an image. For example, the controlsystem 600 can be employed to create of three-dimensional data set forsurgical use in a system with augmentation image overlays. Techniquescan be employed both intraoperatively and preoperatively usingadditional visual information. In various embodiments, the controlsystem 600 is configured to provide warnings to a medical practitionerwhen in the proximity of one or more critical structures. Variousalgorithms can be employed to guide robotic automation andsemi-automated approaches based on the surgical procedure and proximityto the critical structure(s).

A projected array of lights is employed by the control system 600 todetermine tissue shape and motion intraoperatively. Alternatively, flashLidar may be utilized for surface mapping of the tissue.

The control system 600 is configured to detect the critical structure,which as mentioned above can include one or more critical structures,and provide an image overlay of the critical structure and measure thedistance to the surface of the visible tissue and the distance to theembedded/buried critical structure(s). The control system 600 canmeasure the distance to the surface of the visible tissue or detect thecritical structure and provide an image overlay of the criticalstructure.

The control system 600 includes a spectral control circuit 602. Thespectral control circuit 602 can be a field programmable gate array(FPGA) or another suitable circuit configuration, such as theconfigurations described with respect to FIG. 6 , FIG. 7 , and FIG. 8 .The spectral control circuit 602 includes a processor 604 configured toreceive video input signals from a video input processor 606. Theprocessor 604 can be configured for hyperspectral processing and canutilize C/C++ code, for example. The video input processor 606 isconfigured to receive video-in of control (metadata) data such asshutter time, wave length, and sensor analytics, for example. Theprocessor 604 is configured to process the video input signal from thevideo input processor 606 and provide a video output signal to a videooutput processor 608, which includes a hyperspectral video-out ofinterface control (metadata) data, for example. The video outputprocessor 608 is configured to provides the video output signal to animage overlay controller 610.

The video input processor 606 is operatively coupled to a camera 612 atthe patient side via a patient isolation circuit 614. The camera 612includes a solid state image sensor 634. The patient isolation circuit614 can include a plurality of transformers so that the patient isisolated from other circuits in the system. The camera 612 is configuredto receive intraoperative images through optics 632 and the image sensor634. The image sensor 634 can include a CMOS image sensor, for example,or can include another image sensor technology, such as those discussedherein in connection with FIG. 4 . The camera 612 is configured tooutput 613 images in 14 bit/pixel signals. A person skilled in the artwill appreciate that higher or lower pixel resolutions can be employed.The isolated camera output signal 613 is provided to a color RGB fusioncircuit 616, which in this illustrated embodiment employs a hardwareregister 618 and a Nios2 co-processor 620 configured to process thecamera output signal 613. A color RGB fusion output signal is providedto the video input processor 606 and a laser pulsing control circuit622.

The laser pulsing control circuit 622 is configured to control a laserlight engine 624. The laser light engine 624 is configured to outputlight in a plurality of wavelengths (λ1, λ2, λ3, . . . λn) includingnear infrared (NIR). The laser light engine 624 can operate in aplurality of modes. For example, the laser light engine 624 can operatein two modes. In a first mode, e.g., a normal operating mode, the laserlight engine 624 is configured to output an illuminating signal. In asecond mode, e.g., an identification mode, the laser light engine 624 isconfigured to output RGBG and NIR light. In various embodiments, thelaser light engine 624 can operate in a polarizing mode.

Light output 626 from the laser light engine 624 is configured toilluminate targeted anatomy in an intraoperative surgical site 627. Thelaser pulsing control circuit 622 is also configured to control a laserpulse controller 628 for a laser pattern projector 630 configured toproject a laser light pattern 631, such as a grid or pattern of linesand/or dots, at a predetermined wavelength (λ2) on an operative tissueor organ at the surgical site 627. The camera 612 is configured toreceive the patterned light as well as the reflected light outputthrough the camera optics 632. The image sensor 634 is configured toconvert the received light into a digital signal.

The color RGB fusion circuit 616 is also configured to output signals tothe image overlay controller 610 and a video input module 636 forreading the laser light pattern 631 projected onto the targeted anatomyat the surgical site 627 by the laser pattern projector 630. Aprocessing module 638 is configured to process the laser light pattern631 and output a first video output signal 640 representative of thedistance to the visible tissue at the surgical site 627. The data isprovided to the image overlay controller 610. The processing module 638is also configured to output a second video signal 642 representative ofa three-dimensional rendered shape of the tissue or organ of thetargeted anatomy at the surgical site.

The first and second video output signals 640, 642 include datarepresentative of the position of the critical structure on athree-dimensional surface model, which is provided to an integrationmodule 643. In combination with data from the video out processor 608 ofthe spectral control circuit 602, the integration module 643 isconfigured to determine the distance (e.g., distance d_(A) of FIG. 1 )to a buried critical structure (e.g., via triangularization algorithms644), and the distance to the buried critical structure can be providedto the image overlay controller 610 via a video out processor 646. Theforegoing conversion logic can encompass the conversion logic circuit648 intermediate video monitors 652 and the camera 624/laser patternprojector 630 positioned at the surgical site 627.

Preoperative data 650, such as from a CT or MRI scan, can be employed toregister or align certain three-dimensional deformable tissue in variousinstances. Such preoperative data 650 can be provided to the integrationmodule 643 and ultimately to the image overlay controller 610 so thatsuch information can be overlaid with the views from the camera 612 andprovided to the video monitors 652. Embodiments of registration ofpreoperative data are further described in U.S. Pat. Pub. No.2020/0015907 entitled “Integration Of Imaging Data” filed Sep. 11, 2018,which is hereby incorporated by reference herein in its entirety.

The video monitors 652 are configured to output the integrated/augmentedviews from the image overlay controller 610. A medical practitioner canselect and/or toggle between different views on one or more displays. Ona first display 652 a, which is a monitor in this illustratedembodiment, the medical practitioner can toggle between (A) a view inwhich a three-dimensional rendering of the visible tissue is depictedand (B) an augmented view in which one or more hidden criticalstructures are depicted over the three-dimensional rendering of thevisible tissue. On a second display 652 b, which is a monitor in thisillustrated embodiment, the medical practitioner can toggle on distancemeasurements to one or more hidden critical structures and/or thesurface of visible tissue, for example.

The various surgical visualization systems described herein can beutilized to visualize various different types of tissues and/oranatomical structures, including tissues and/or anatomical structuresthat may be obscured from being visualized by EMR in the visible portionof the spectrum. The surgical visualization system can utilize aspectral imaging system, as mentioned above, which can be configured tovisualize different types of tissues based upon their varyingcombinations of constituent materials. In particular, a spectral imagingsystem can be configured to detect the presence of various constituentmaterials within a tissue being visualized based on the absorptioncoefficient of the tissue across various EMR wavelengths. The spectralimaging system can be configured to characterize the tissue type of thetissue being visualized based upon the particular combination ofconstituent materials.

FIG. 10 shows a graph 300 depicting how the absorption coefficient ofvarious biological materials varies across the EMR wavelength spectrum.In the graph 300, the vertical axis 302 represents absorptioncoefficient of the biological material in cm⁻¹, and the horizontal axis304 represents EMR wavelength in μm. A first line 306 in the graph 300represents the absorption coefficient of water at various EMRwavelengths, a second line 308 represents the absorption coefficient ofprotein at various EMR wavelengths, a third line 310 represents theabsorption coefficient of melanin at various EMR wavelengths, a fourthline 312 represents the absorption coefficient of deoxygenatedhemoglobin at various EMR wavelengths, a fifth line 314 represents theabsorption coefficient of oxygenated hemoglobin at various EMRwavelengths, and a sixth line 316 represents the absorption coefficientof collagen at various EMR wavelengths. Different tissue types havedifferent combinations of constituent materials and, therefore, thetissue type(s) being visualized by a surgical visualization system canbe identified and differentiated between according to the particularcombination of detected constituent materials. Accordingly, a spectralimaging system of a surgical visualization system can be configured toemit EMR at a number of different wavelengths, determine the constituentmaterials of the tissue based on the detected absorption EMR absorptionresponse at the different wavelengths, and then characterize the tissuetype based on the particular detected combination of constituentmaterials.

FIG. 11 shows an embodiment of the utilization of spectral imagingtechniques to visualize different tissue types and/or anatomicalstructures. In FIG. 11 , a spectral emitter 320 (e.g., the spectrallight source 150 of FIG. 4 ) is being utilized by an imaging system tovisualize a surgical site 322. The EMR emitted by the spectral emitter320 and reflected from the tissues and/or structures at the surgicalsite 322 is received by an image sensor (e.g., the image sensor 135 ofFIG. 4 ) to visualize the tissues and/or structures, which can be eithervisible (e.g., be located at a surface of the surgical site 322) orobscured (e.g., underlay other tissue and/or structures at the surgicalsite 322). In this embodiment, an imaging system (e.g., the imagingsystem 142 of FIG. 4 ) visualizes a tumor 324, an artery 326, andvarious abnormalities 328 (e.g., tissues not confirming to known orexpected spectral signatures) based upon the spectral signaturescharacterized by the differing absorptive characteristics (e.g.,absorption coefficient) of the constituent materials for each of thedifferent tissue/structure types. The visualized tissues and structurescan be displayed on a display screen associated with or coupled to theimaging system (e.g., the display 146 of the imaging system 142 of FIG.4 ), on a primary display (e.g., the primary display 819 of FIG. 19 ),on a non-sterile display (e.g., the non-sterile displays 807, 809 ofFIG. 19 ), on a display of a surgical hub (e.g., the display of thesurgical hub 806 of FIG. 19 ), on a device/instrument display, and/or onanother display.

The imaging system can be configured to tailor or update the displayedsurgical site visualization according to the identified tissue and/orstructure types. For example, as shown in FIG. 11 , the imaging systemcan display a margin 330 associated with the tumor 324 being visualizedon a display screen associated with or coupled to the imaging system, ona primary display, on a non-sterile display, on a display of a surgicalhub, on a device/instrument display, and/or on another display. Themargin 330 can indicate the area or amount of tissue that should beexcised to ensure complete removal of the tumor 324. A size of themargin 330 can be, for example, in a range of about 5 mm to about 10 mm.The surgical visualization system's control system (e.g., the controlsystem 133 of FIG. 4 ) can be configured to control or update thedimensions of the margin 330 based on the tissues and/or structuresidentified by the imaging system. In this illustrated embodiment, theimaging system has identified multiple abnormalities 328 within thefield of view (FOV). Accordingly, the control system can adjust thedisplayed margin 330 to a first updated margin 332 having sufficientdimensions to encompass the abnormalities 328. Further, the imagingsystem has also identified the artery 326 partially overlapping with theinitially displayed margin 330 (as indicated by a highlighted region 334of the artery 326). Accordingly, the control system can adjust thedisplayed margin to a second updated margin 336 having sufficientdimensions to encompass the relevant portion of the artery 326.

Tissues and/or structures can also be imaged or characterized accordingto their reflective characteristics, in addition to or in lieu of theirabsorptive characteristics described above with respect to FIG. 10 andFIG. 11 , across the EMR wavelength spectrum. For example, FIG. 12 ,FIG. 13 , and FIG. 14 illustrate various graphs of reflectance ofdifferent types of tissues or structures across different EMRwavelengths. FIG. 12 is a graphical representation 340 of anillustrative ureter signature versus obscurants. FIG. 13 is a graphicalrepresentation 342 of an illustrative artery signature versusobscurants. FIG. 14 is a graphical representation 344 of an illustrativenerve signature versus obscurants. The plots in FIG. 12 , FIG. 13 , andFIG. 14 represent reflectance as a function of wavelength (nm) for theparticular structures (ureter, artery, and nerve) relative to thecorresponding reflectances of fat, lung tissue, and blood at thecorresponding wavelengths. These graphs are simply for illustrativepurposes and it should be understood that other tissues and/orstructures could have corresponding detectable reflectance signaturesthat would allow the tissues and/or structures to be identified andvisualized.

Select wavelengths for spectral imaging can be identified and utilizedbased on the anticipated critical structures and/or obscurants at asurgical site (e.g., “selective spectral” imaging). By utilizingselective spectral imaging, the amount of time required to obtain thespectral image can be minimized such that the information can beobtained in real-time and utilized intraoperatively. The wavelengths canbe selected by a medical practitioner or by a control circuit based oninput by a user, e.g., a medical practitioner. In certain instances, thewavelengths can be selected based on machine learning and/or big dataaccessible to the control circuit via, e.g., a cloud or surgical hub.

FIG. 15 illustrates one embodiment of spectral imaging to tissue beingutilized intraoperatively to measure a distance between a waveformemitter and a critical structure that is obscured by tissue. FIG. 15shows an embodiment of a time-of-flight sensor system 404 utilizingwaveforms 424, 425. The time-of-flight sensor system 404 can beincorporated into a surgical visualization system, e.g., as the sensorsystem 104 of the surgical visualization system 100 of FIG. 1 . Thetime-of-flight sensor system 404 includes a waveform emitter 406 and awaveform receiver 408 on the same surgical device 402 (e.g., the emitter106 and the receiver 108 on the same surgical device 102 of FIG. 1 ).The emitted wave 400 extends to a critical structure 401 (e.g., thecritical structure 101 of FIG. 1 ) from the emitter 406, and thereceived wave 425 is reflected back to by the receiver 408 from thecritical structure 401. The surgical device 402 in this illustratedembodiment is positioned through a trocar 410 that extends into a cavity407 in a patient. Although the trocar 410 is used in this in thisillustrated embodiment, other trocars or other access devices can beused, or no access device may be used.

The waveforms 424, 425 are configured to penetrate obscuring tissue 403,such as by having wavelengths in the NIR or SWIR spectrum ofwavelengths. A spectral signal (e.g., hyperspectral, multispectral, orselective spectral) or a photoacoustic signal is emitted from theemitter 406, as shown by a first arrow 407 pointing distally, and canpenetrate the tissue 403 in which the critical structure 401 isconcealed. The emitted waveform 424 is reflected by the criticalstructure 401, as shown by a second arrow 409 pointing proximally. Thereceived waveform 425 can be delayed due to a distance d between adistal end of the surgical device 402 and the critical structure 401.The waveforms 424, 425 can be selected to target the critical structure401 within the tissue 403 based on the spectral signature of thecritical structure 401, as described herein. The emitter 406 isconfigured to provide a binary signal on and off, as shown in FIG. 16 ,for example, which can be measured by the receiver 408.

Based on the delay between the emitted wave 424 and the received wave425, the time-of-flight sensor system 404 is configured to determine thedistance d. A time-of-flight timing diagram 430 for the emitter 406 andthe receiver 408 of FIG. 15 is shown in FIG. 16 . The delay is afunction of the distance d and the distance d is given by:

$d = {\frac{ct}{2} \cdot \frac{q_{2}}{q_{1} + q_{2}}}$

where c=the speed of light; t=length of pulse; q₁=accumulated chargewhile light is emitted; and q₂=accumulated charge while light is notbeing emitted.

The time-of-flight of the waveforms 424, 425 corresponds to the distanced in FIG. 15 . In various instances, additional emitters/receiversand/or pulsing signals from the emitter 406 can be configured to emit anon-penetrating signal. The non-penetrating signal can be configured todetermine the distance from the emitter 406 to the surface 405 of theobscuring tissue 403. In various instances, a depth of the criticalstructure 401 can be determined by:

d _(A) =d _(w) −d _(t)

where d_(A)=the depth of the critical structure 401; d_(w)=the distancefrom the emitter 406 to the critical structure 401 (d in FIG. 15 ); andd_(t,)=the distance from the emitter 406 (on the distal end of thesurgical device 402) to the surface 405 of the obscuring tissue 403.

FIG. 17 illustrates another embodiment of a time-of-flight sensor system504 utilizing waves 524 a, 524 b, 524 c, 525 a, 525 b, 525 c is shown.The time-of-flight sensor system 504 can be incorporated into a surgicalvisualization system, e.g., as the sensor system 104 of the surgicalvisualization system 100 of FIG. 1 . The time-of-flight sensor system504 includes a waveform emitter 506 and a waveform receiver 508 (e.g.,the emitter 106 and the receiver 108 of FIG. 1 ). The waveform emitter506 is positioned on a first surgical device 502 a (e.g., the surgicaldevice 102 of FIG. 1 ), and the waveform receiver 508 is positioned on asecond surgical device 502 b. The surgical devices 502 a, 502 b arepositioned through first and second trocars 510 a, 510 b, respectively,which extend into a cavity 507 in a patient. Although the trocars 510 a,510 b are used in this in this illustrated embodiment, other trocars orother access devices can be used, or no access device may be used. Theemitted waves 524 a, 524 b, 524 c extend toward a surgical site from theemitter 506, and the received waves 525 a, 525 b, 525 c are reflectedback to the receiver 508 from various structures and/or surfaces at thesurgical site.

The different emitted waves 524 a, 524 b, 524 c are configured to targetdifferent types of material at the surgical site. For example, the wave524 a targets obscuring tissue 503, the wave 524 b targets a firstcritical structure 501 a (e.g., the critical structure 101 of FIG. 1 ),which is a vessel in this illustrated embodiment, and the wave 524 ctargets a second critical structure 501 b (e.g., the critical structure101 of FIG. 1 ), which is a cancerous tumor in this illustratedembodiment. The wavelengths of the waves 524 a, 524 b, 524 c can be inthe visible light, NIR, or SWIR spectrum of wavelengths. For example,visible light can be reflected off a surface 505 of the tissue 503, andNIR and/or SWIR waveforms can penetrate the surface 505 of the tissue503. In various aspects, as described herein, a spectral signal (e.g.,hyperspectral, multispectral, or selective spectral) or a photoacousticsignal can be emitted from the emitter 506. The waves 524 b, 524 c canbe selected to target the critical structures 501 a, 501 b within thetissue 503 based on the spectral signature of the critical structures501 a, 501 b, as described herein. Photoacoustic imaging is furtherdescribed in various U.S. patent applications, which are incorporated byreference herein in the present disclosure.

The emitted waves 524 a, 524 b, 524 c are reflected off the targetedmaterial, namely the surface 505, the first critical structure 501 a,and the second structure 501 b, respectively. The received waveforms 525a, 525 b, 525 c can be delayed due to distances d_(1a), d_(2a), d_(3a),d_(1b), d_(2b), d_(2c).

In the time-of-flight sensor system 504, in which the emitter 506 andthe receiver 508 are independently positionable (e.g., on separatesurgical devices 502 a, 502 b and/or controlled by separate roboticarms), the various distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c) can be calculated from the known position of the emitter 506 andthe receiver 508. For example, the positions can be known when thesurgical devices 502 a, 502 b are robotically-controlled. Knowledge ofthe positions of the emitter 506 and the receiver 508, as well as thetime of the photon stream to target a certain tissue and the informationreceived by the receiver 508 of that particular response can allow adetermination of the distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c). In one aspect, the distance to the obscured critical structures501 a, 501 b can be triangulated using penetrating wavelengths. Becausethe speed of light is constant for any wavelength of visible orinvisible light, the time-of-flight sensor system 504 can determine thevarious distances.

In a view provided to the medical practitioner, such as on a display,the receiver 508 can be rotated such that a center of mass of the targetstructure in the resulting images remains constant, e.g., in a planeperpendicular to an axis of a select target structure 503, 501 a, or 501b. Such an orientation can quickly communicate one or more relevantdistances and/or perspectives with respect to the target structure. Forexample, as shown in FIG. 17 , the surgical site is displayed from aviewpoint in which the critical structure 501 a is perpendicular to theviewing plane (e.g., the vessel is oriented in/out of the page). Such anorientation can be default setting; however, the view can be rotated orotherwise adjusted by a medical practitioner. In certain instances, themedical practitioner can toggle between different surfaces and/or targetstructures that define the viewpoint of the surgical site provided bythe imaging system.

As in this illustrated embodiment, the receiver 508 can be mounted onthe trocar 510 b (or other access device) through which the surgicaldevice 502 b is positioned. In other embodiments, the receiver 508 canbe mounted on a separate robotic arm for which the three-dimensionalposition is known. In various instances, the receiver 508 can be mountedon a movable arm that is separate from a robotic surgical system thatcontrols the surgical device 502 a or can be mounted to an operatingroom (OR) table or fixture that is intraoperatively registerable to therobot coordinate plane. In such instances, the position of the emitter506 and the receiver 508 can be registerable to the same coordinateplane such that the distances can be triangulated from outputs from thetime-of-flight sensor system 504.

Combining time-of-flight sensor systems and near-infrared spectroscopy(NIRS), termed TOF-NIRS, which is capable of measuring the time-resolvedprofiles of NIR light with nanosecond resolution can be found in“Time-Of-Flight Near-Infrared Spectroscopy For NondestructiveMeasurement Of Internal Quality In Grapefruit,” Journal of the AmericanSociety for Horticultural Science, May 2013 vol. 138 no. 3 225-228,which is hereby incorporated by reference in its entirety.

Embodiments of visualization systems and aspects and uses thereof aredescribed further in U.S. Pat. Pub. No. 2020/0015923 entitled “SurgicalVisualization Platform” filed Sep. 11, 2018, U.S. Pat. Pub. No.2020/0015900 entitled “Controlling An Emitter Assembly Pulse Sequence”filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015668 entitled “SingularEMR Source Emitter Assembly” filed Sep. 11, 2018, U.S. Pat. Pub. No.2020/0015925 entitled “Combination Emitter And Camera Assembly” filedSep. 11, 2018, U.S. Pat. Pub. No. 2020/0015899 entitled “SurgicalVisualization With Proximity Tracking Features” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2020/0015903 entitled “Surgical Visualization OfMultiple Targets” filed Sep. 11, 2018, U.S. Pat. No. 10,792,034 entitled“Visualization Of Surgical Devices” filed Sep. 11, 2018, U.S. Pat. Pub.No. 2020/0015897 entitled “Operative Communication Of Light” filed Sep.11, 2018, U.S. Pat. Pub. No. 2020/0015924 entitled “Robotic LightProjection Tools” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015898entitled “Surgical Visualization Feedback System” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2020/0015906 entitled “Surgical Visualization AndMonitoring” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015907entitled “Integration Of Imaging Data” filed Sep. 11, 2018, U.S. Pat.No. 10,925,598 entitled “Robotically-Assisted Surgical Suturing Systems”filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015901 entitled “SafetyLogic For Surgical Suturing Systems” filed Sep. 11, 2018, U.S. Pat. Pub.No. 2020/0015914 entitled “Robotic Systems With Separate PhotoacousticReceivers” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015902 entitled“Force Sensor Through Structured Light Deflection” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2019/0201136 entitled “Method Of Hub Communication”filed Dec. 4, 2018, U.S. patent application Ser. No. 16/729,772 entitled“Analyzing Surgical Trends By A Surgical System” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,747 entitled “Dynamic SurgicalVisualization Systems” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,744 entitled “Visualization Systems Using Structured Light”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,778entitled “System And Method For Determining, Adjusting, And ManagingResection Margin About A Subject Tissue” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,729 entitled “Surgical Systems ForProposing And Corroborating Organ Portion Removals” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,778 entitled “Surgical SystemFor Overlaying Surgical Instrument Data Onto A Virtual Three DimensionalConstruct Of An Organ” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,751 entitled “Surgical Systems For Generating ThreeDimensional Constructs Of Anatomical Organs And Coupling IdentifiedAnatomical Structures Thereto” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,740 entitled “Surgical Systems CorrelatingVisualization Data And Powered Surgical Instrument Data” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,737 entitled “AdaptiveSurgical System Control According To Surgical Smoke CloudCharacteristics” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,807 entitled “Method Of Using Imaging Devices In Surgery”filed Dec. 30, 2019, U.S. patent application Ser. No. 17/493,913entitled “Surgical Methods Using Fiducial Identification And Tracking”filed on Oct. 5, 2021, U.S. patent application Ser. No. 17/494,364entitled “Surgical Methods For Control Of One Visualization WithAnother” filed on Oct. 5, 2021, U.S. patent application Ser. No.17/450,020 entitled “Methods And Systems For Controlling CooperativeSurgical Instruments” filed on Oct. 5, 2021, U.S. patent applicationSer. No. 17/450,025 entitled “Methods And Systems For ControllingCooperative Surgical Instruments With Variable Surgical Site AccessTrajectories” filed on Oct. 5, 2021, U.S. patent application Ser. No.17/450,027 entitled “Methods And Systems For Controlling CooperativeSurgical Instruments” filed on Oct. 5, 2021, and U.S. patent applicationSer. No. 17/449,765 entitled “Cooperative Access Hybrid Procedures”filed Oct. 1, 2021, which are hereby incorporated by reference in theirentireties.

Surgical Hubs

The various visualization or imaging systems described herein can beincorporated into a system that includes a surgical hub. In general, asurgical hub can be a component of a comprehensive digital medicalsystem capable of spanning multiple medical facilities and configured toprovide integrated and comprehensive improved medical care to a vastnumber of patients. The comprehensive digital medical system includes acloud-based medical analytics system that is configured to interconnectto multiple surgical hubs located across many different medicalfacilities. The surgical hubs are configured to interconnect with one ormore elements, such as one or more surgical instruments that are used toconduct medical procedures on patients and/or one or more visualizationsystems that are used during performance of medical procedures. Thesurgical hubs provide a wide array of functionality to improve theoutcomes of medical procedures. The data generated by the varioussurgical devices, visualization systems, and surgical hubs about thepatient and the medical procedure may be transmitted to the cloud-basedmedical analytics system. This data may then be aggregated with similardata gathered from many other surgical hubs, visualization systems, andsurgical instruments located at other medical facilities. Variouspatterns and correlations may be found through the cloud-based analyticssystem analyzing the collected data. Improvements in the techniques usedto generate the data may be generated as a result, and theseimprovements may then be disseminated to the various surgical hubs,visualization systems, and surgical instruments. Due to theinterconnectedness of all of the aforementioned components, improvementsin medical procedures and practices may be found that otherwise may notbe found if the many components were not so interconnected.

Examples of surgical hubs configured to receive, analyze, and outputdata, and methods of using such surgical hubs, are further described inU.S. Pat. Pub. No. 2019/0200844 entitled “Method Of Hub Communication,Processing, Storage And Display” filed Dec. 4, 2018, U.S. Pat. Pub. No.2019/0200981 entitled “Method Of Compressing Tissue Within A StaplingDevice And Simultaneously Displaying The Location Of The Tissue WithinThe Jaws” filed Dec. 4, 2018, U.S. Pat. Pub. No. 2019/0201046 entitled“Method For Controlling Smart Energy Devices” filed Dec. 4, 2018, U.S.Pat. Pub. No. 2019/0201114 entitled “Adaptive Control Program UpdatesFor Surgical Hubs” filed Mar. 29, 2018, U.S. Pat. Pub. No. 2019/0201140entitled “Surgical Hub Situational Awareness” filed Mar. 29, 2018, U.S.Pat. Pub. No. 2019/0206004 entitled “Interactive Surgical Systems WithCondition Handling Of Devices And Data Capabilities” filed Mar. 29,2018, U.S. Pat. Pub. No. 2019/0206555 entitled “Cloud-based MedicalAnalytics For Customization And Recommendations To A User” filed Mar.29, 2018, and U.S. Pat. Pub. No. 2019/0207857 entitled “Surgical NetworkDetermination Of Prioritization Of Communication, Interaction, OrProcessing Based On System Or Device Needs” filed Nov. 6, 2018, whichare hereby incorporated by reference in their entireties.

FIG. 18 illustrates one embodiment of a computer-implemented interactivesurgical system 700 that includes one or more surgical systems 702 and acloud-based system (e.g., a cloud 704 that can include a remote server713 coupled to a storage device 705). Each surgical system 702 includesat least one surgical hub 706 in communication with the cloud 704. Inone example, as illustrated in FIG. 18 , the surgical system 702includes a visualization system 708, a robotic system 710, and anintelligent (or “smart”) surgical instrument 712, which are configuredto communicate with one another and/or the hub 706. The intelligentsurgical instrument 712 can include imaging device(s). The surgicalsystem 702 can include an M number of hubs 706, an N number ofvisualization systems 708, an O number of robotic systems 710, and a Pnumber of intelligent surgical instruments 712, where M, N, O, and P areintegers greater than or equal to one that may or may not be equal toany one or more of each other. Various exemplary intelligent surgicalinstruments and robotic systems are described herein.

Data received by a surgical hub from a surgical visualization system canbe used in any of a variety of ways. In an exemplary embodiment, thesurgical hub can receive data from a surgical visualization system inuse with a patient in a surgical setting, e.g., in use in an operatingroom during performance of a surgical procedure. The surgical hub canuse the received data in any of one or more ways, as discussed herein.

The surgical hub can be configured to analyze received data in real timewith use of the surgical visualization system and adjust control one ormore of the surgical visualization system and/or one or more intelligentsurgical instruments in use with the patient based on the analysis ofthe received data. Such adjustment can include, for example, adjustingone or operational control parameters of intelligent surgicalinstrument(s), causing one or more sensors of one or more intelligentsurgical instruments to take a measurement to help gain an understandingof the patient's current physiological condition, and/or currentoperational status of an intelligent surgical instrument, and otheradjustments. Controlling and adjusting operation of intelligent surgicalinstruments is discussed further below. Examples of operational controlparameters of an intelligent surgical instrument include motor speed,cutting element speed, time, duration, level of energy application, andlight emission. Examples of surgical hubs and of controlling andadjusting intelligent surgical instrument operation are describedfurther in previously mentioned U.S. patent application Ser. No.16/729,772 entitled “Analyzing Surgical Trends By A Surgical System”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,747entitled “Dynamic Surgical Visualization Systems” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,744 entitled “VisualizationSystems Using Structured Light” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,778 entitled “System And Method ForDetermining, Adjusting, And Managing Resection Margin About A SubjectTissue” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,729entitled “Surgical Systems For Proposing And Corroborating Organ PortionRemovals” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,778 entitled “Surgical System For Overlaying Surgical InstrumentData Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,751 entitled “SurgicalSystems For Generating Three Dimensional Constructs Of Anatomical OrgansAnd Coupling Identified Anatomical Structures Thereto” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,740 entitled “SurgicalSystems Correlating Visualization Data And Powered Surgical InstrumentData” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,737entitled “Adaptive Surgical System Control According To Surgical SmokeCloud Characteristics” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, and U.S. patent applicationSer. No. 16/729,807 entitled “Method Of Using Imaging Devices InSurgery” filed Dec. 30, 2019, and in U.S. patent application Ser. No.17/068,857 entitled “Adaptive Responses From Smart Packaging Of DrugDelivery Absorbable Adjuncts” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,858 entitled “Drug Administration DevicesThat Communicate With Surgical Hubs” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,859 entitled “Controlling Operation Of DrugAdministration Devices Using Surgical Hubs” filed Oct. 13, 2020, U.S.patent application Ser. No. 17/068,863 entitled “Patient MonitoringUsing Drug Administration Devices” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,865 entitled “Monitoring And CommunicatingInformation Using Drug Administration Devices” filed Oct. 13, 2020, andU.S. patent application Ser. No. 17/068,867 entitled “Aggregating AndAnalyzing Drug Administration Data” filed Oct. 13, 2020, which arehereby incorporated by reference in their entireties.

The surgical hub can be configured to cause visualization of thereceived data to be provided in the surgical setting on a display sothat a medical practitioner in the surgical setting can view the dataand thereby receive an understanding of the operation of the imagingdevice(s) in use in the surgical setting. Such information provided viavisualization can include text and/or images.

FIG. 19 illustrates one embodiment of a surgical system 802 including asurgical hub 806 (e.g., the surgical hub 706 of FIG. 18 or othersurgical hub described herein), a robotic surgical system 810 (e.g., therobotic surgical system 110 of FIG. 1 or other robotic surgical systemherein), and a visualization system 808 (e.g., the visualization system100 of FIG. 1 or other visualization system described herein). Thesurgical hub 806 can be in communication with a cloud, as discussedherein. FIG. 19 shows the surgical system 802 being used to perform asurgical procedure on a patient who is lying down on an operating table814 in a surgical operating room 816. The robotic system 810 includes asurgeon's console 818, a patient side cart 820 (surgical robot), and arobotic system surgical hub 822. The robotic system surgical hub 822 isgenerally configured similar to the surgical hub 822 and can be incommunication with a cloud. In some embodiments, the robotic systemsurgical hub 822 and the surgical hub 806 can be combined. The patientside cart 820 can manipulate an intelligent surgical tool 812 through aminimally invasive incision in the body of the patient while a medicalpractitioner, e.g., a surgeon, nurse, and/or other medical practitioner,views the surgical site through the surgeon's console 818. An image ofthe surgical site can be obtained by an imaging device 824 (e.g., theimaging device 120 of FIG. 1 or other imaging device described herein),which can be manipulated by the patient side cart 820 to orient theimaging device 824. The robotic system surgical hub 822 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 818.

A primary display 819 is positioned in the sterile field of theoperating room 816 and is configured to be visible to an operator at theoperating table 814. In addition, as in this illustrated embodiment, avisualization tower 811 can positioned outside the sterile field. Thevisualization tower 811 includes a first non-sterile display 807 and asecond non-sterile display 809, which face away from each other. Thevisualization system 808, guided by the surgical hub 806, is configuredto utilize the displays 807, 809, 819 to coordinate information flow tomedical practitioners inside and outside the sterile field. For example,the surgical hub 806 can cause the visualization system 808 to display asnapshot and/or a video of a surgical site, as obtained by the imagingdevice 824, on one or both of the non-sterile displays 807, 809, whilemaintaining a live feed of the surgical site on the primary display 819.The snapshot and/or video on the non-sterile display 807 and/or 809 canpermit a non-sterile medical practitioner to perform a diagnostic steprelevant to the surgical procedure, for example.

The surgical hub 806 is configured to route a diagnostic input orfeedback entered by a non-sterile medical practitioner at thevisualization tower 811 to the primary display 819 within the sterilefield, where it can be viewed by a sterile medical practitioner at theoperating table 814. For example, the input can be in the form of amodification to the snapshot and/or video displayed on the non-steriledisplay 807 and/or 809, which can be routed to the primary display 819by the surgical hub 806.

The surgical hub 806 is configured to coordinate information flow to adisplay of the intelligent surgical instrument 812, as is described invarious U.S. Patent Applications that are incorporated by referenceherein in the present disclosure. A diagnostic input or feedback enteredby a non-sterile operator at the visualization tower 818 can be routedby the surgical hub 806 to the display 819 within the sterile field,where it can be viewed by the operator of the surgical instrument 812and/or by other medical practitioner(s) in the sterile field.

The intelligent surgical instrument 812 and the imaging device 824,which is also an intelligent surgical tool, is being used with thepatient in the surgical procedure as part of the surgical system 802.Other intelligent surgical instruments 812 a that can be used in thesurgical procedure, e.g., that can be removably coupled to the patientside cart 820 and be in communication with the robotic surgical system810 and the surgical hub 806, are also shown in FIG. 19 as beingavailable. Non-intelligent (or “dumb”) surgical instruments 817, e.g.,scissors, trocars, cannulas, scalpels, etc., that cannot be incommunication with the robotic surgical system 810 and the surgical hub806 are also shown in FIG. 19 as being available for use.

Operating Intelligent Surgical Instruments

An intelligent surgical device can have an algorithm stored thereon,e.g., in a memory thereof, configured to be executable on board theintelligent surgical device, e.g., by a processor thereof, to controloperation of the intelligent surgical device. In some embodiments,instead of or in addition to being stored on the intelligent surgicaldevice, the algorithm can be stored on a surgical hub, e.g., in a memorythereof, that is configured to communicate with the intelligent surgicaldevice.

The algorithm is stored in the form of one or more sets of pluralitiesof data points defining and/or representing instructions, notifications,signals, etc. to control functions of the intelligent surgical device.In some embodiments, data gathered by the intelligent surgical devicecan be used by the intelligent surgical device, e.g., by a processor ofthe intelligent surgical device, to change at least one variableparameter of the algorithm. As discussed above, a surgical hub can be incommunication with an intelligent surgical device, so data gathered bythe intelligent surgical device can be communicated to the surgical huband/or data gathered by another device in communication with thesurgical hub can be communicated to the surgical hub, and data can becommunicated from the surgical hub to the intelligent surgical device.Thus, instead of or in addition to the intelligent surgical device beingconfigured to change a stored variable parameter, the surgical hub canbe configured to communicate the changed at least one variable, alone oras part of the algorithm, to the intelligent surgical device and/or thesurgical hub can communicate an instruction to the intelligent surgicaldevice to change the at least one variable as determined by the surgicalhub.

The at least one variable parameter is among the algorithm's datapoints, e.g., are included in instructions for operating the intelligentsurgical device, and are thus each able to be changed by changing one ormore of the stored pluralities of data points of the algorithm. Afterthe at least one variable parameter has been changed, subsequentexecution of the algorithm is according to the changed algorithm. Assuch, operation of the intelligent surgical device over time can bemanaged for a patient to increase the beneficial results use of theintelligent surgical device by taking into consideration actualsituations of the patient and actual conditions and/or results of thesurgical procedure in which the intelligent surgical device is beingused. Changing the at least one variable parameter is automated toimprove patient outcomes. Thus, the intelligent surgical device can beconfigured to provide personalized medicine based on the patient and thepatient's surrounding conditions to provide a smart system. In asurgical setting in which the intelligent surgical device is being usedduring performance of a surgical procedure, automated changing of the atleast one variable parameter may allow for the intelligent surgicaldevice to be controlled based on data gathered during the performance ofthe surgical procedure, which may help ensure that the intelligentsurgical device is used efficiently and correctly and/or may help reducechances of patient harm by harming a critical anatomical structure.

The at least one variable parameter can be any of a variety of differentoperational parameters. Examples of variable parameters include motorspeed, motor torque, energy level, energy application duration, tissuecompression rate, jaw closure rate, cutting element speed, loadthreshold, etc.

FIG. 20 illustrates one embodiment of an intelligent surgical instrument900 including a memory 902 having an algorithm 904 stored therein thatincludes at least one variable parameter. The algorithm 904 can be asingle algorithm or can include a plurality of algorithms, e.g.,separate algorithms for different aspects of the surgical instrument'soperation, where each algorithm includes at least one variableparameter. The intelligent surgical instrument 900 can be the surgicaldevice 102 of FIG. 1 , the imaging device 120 of FIG. 1 , the surgicaldevice 202 of FIG. 8 , the imaging device 220 of FIG. 8 , the surgicaldevice 402 of FIG. 15 , the surgical device 502 a of FIG. 17 , thesurgical device 502 b of FIG. 17 , the surgical device 712 of FIG. 18 ,the surgical device 812 of FIG. 19 , the imaging device 824 of FIG. 19 ,or other intelligent surgical instrument. The surgical instrument 900also includes a processor 906 configured to execute the algorithm 904 tocontrol operation of at least one aspect of the surgical instrument 900.To execute the algorithm 904, the processor 906 is configured to run aprogram stored in the memory 902 to access a plurality of data points ofthe algorithm 904 in the memory 902.

The surgical instrument 900 also includes a communications interface908, e.g., a wireless transceiver or other wired or wirelesscommunications interface, configured to communicate with another device,such as a surgical hub 910. The communications interface 908 can beconfigured to allow one-way communication, such as providing data to aremote server (e.g., a cloud server or other server) and/or to a local,surgical hub server, and/or receiving instructions or commands from aremote server and/or a local, surgical hub server, or two-waycommunication, such as providing information, messages, data, etc.regarding the surgical instrument 900 and/or data stored thereon andreceiving instructions, such as from a doctor; a remote server regardingupdates to software; a local, surgical hub server regarding updates tosoftware; etc.

The surgical instrument 900 is simplified in FIG. 20 and can includeadditional components, e.g., a bus system, a handle, a elongate shafthaving an end effector at a distal end thereof, a power source, etc. Theprocessor 906 can also be configured to execute instructions stored inthe memory 902 to control the device 900 generally, including otherelectrical components thereof such as the communications interface 908,an audio speaker, a user interface, etc.

The processor 906 is configured to change at least one variableparameter of the algorithm 904 such that a subsequent execution of thealgorithm 904 will be in accordance with the changed at least onevariable parameter. To change the at least one variable parameter of thealgorithm 904, the processor 906 is configured to modify or update thedata point(s) of the at least one variable parameter in the memory 902.The processor 906 can be configured to change the at least one variableparameter of the algorithm 904 in real time with use of the surgicaldevice 900 during performance of a surgical procedure, which mayaccommodate real time conditions.

Additionally or alternatively to the processor 906 changing the at leastone variable parameter, the processor 906 can be configured to changethe algorithm 904 and/or at least one variable parameter of thealgorithm 904 in response to an instruction received from the surgicalhub 910. In some embodiments, the processor 906 is configured to changethe at least one variable parameter only after communicating with thesurgical hub 910 and receiving an instruction therefrom, which may helpensure coordinated action of the surgical instrument 900 with otheraspects of the surgical procedure in which the surgical instrument 900is being used.

In an exemplary embodiment, the processor 906 executes the algorithm 904to control operation of the surgical instrument 900, changes the atleast one variable parameter of the algorithm 904 based on real timedata, and executes the algorithm 904 after changing the at least onevariable parameter to control operation of the surgical instrument 900.

FIG. 21 illustrates one embodiment of a method 912 of using of thesurgical instrument 900 including a change of at least one variableparameter of the algorithm 904. The processor 906 controls 914 operationof the surgical instrument 900 by executing the algorithm 904 stored inthe memory 902. Based on any of this subsequently known data and/orsubsequently gathered data, the processor 904 changes 916 the at leastone variable parameter of the algorithm 904 as discussed above. Afterchanging the at least one variable parameter, the processor 906 controls918 operation of the surgical instrument 900 by executing the algorithm904, now with the changed at least one variable parameter. The processor904 can change 916 the at least one variable parameter any number oftimes during performance of a surgical procedure, e.g., zero, one, two,three, etc. During any part of the method 912, the surgical instrument900 can communicate with one or more computer systems, e.g., thesurgical hub 910, a remote server such as a cloud server, etc., usingthe communications interface 908 to provide data thereto and/or receiveinstructions therefrom.

Situational Awareness

Operation of an intelligent surgical instrument can be altered based onsituational awareness of the patient. The operation of the intelligentsurgical instrument can be altered manually, such as by a user of theintelligent surgical instrument handling the instrument differently,providing a different input to the instrument, ceasing use of theinstrument, etc. Additionally or alternatively, the operation of anintelligent surgical instrument can be changed automatically by analgorithm of the instrument being changed, e.g., by changing at leastone variable parameter of the algorithm. As mentioned above, thealgorithm can be adjusted automatically without user input requestingthe change. Automating the adjustment during performance of a surgicalprocedure may help save time, may allow medical practitioners to focuson other aspects of the surgical procedure, and/or may ease the processof using the surgical instrument for a medical practitioner, which eachmay improve patient outcomes, such as by avoiding a critical structure,controlling the surgical instrument with consideration of a tissue typethe instrument is being used on and/or near, etc.

The visualization systems described herein can be utilized as part of asituational awareness system that can be embodied or executed by asurgical hub, e.g., the surgical hub 706, the surgical hub 806, or othersurgical hub described herein. In particular, characterizing,identifying, and/or visualizing surgical instruments (including theirpositions, orientations, and actions), tissues, structures, users,and/or other things located within the surgical field or the operatingtheater can provide contextual data that can be utilized by asituational awareness system to infer various information, such as atype of surgical procedure or a step thereof being performed, a type oftissue(s) and/or structure(s) being manipulated by a surgeon or othermedical practitioner, and other information. The contextual data canthen be utilized by the situational awareness system to provide alertsto a user, suggest subsequent steps or actions for the user toundertake, prepare surgical devices in anticipation for their use (e.g.,activate an electrosurgical generator in anticipation of anelectrosurgical instrument being utilized in a subsequent step of thesurgical procedure, etc.), control operation of intelligent surgicalinstruments (e.g., customize surgical instrument operational parametersof an algorithm as discussed further below), and so on.

Although an intelligent surgical device including an algorithm thatresponds to sensed data, e.g., by having at least one variable parameterof the algorithm changed, can be an improvement over a “dumb” devicethat operates without accounting for sensed data, some sensed data canbe incomplete or inconclusive when considered in isolation, e.g.,without the context of the type of surgical procedure being performed orthe type of tissue that is being operated on. Without knowing theprocedural context (e.g., knowing the type of tissue being operated onor the type of procedure being performed), the algorithm may control thesurgical device incorrectly or sub-optimally given the particularcontext-free sensed data. For example, the optimal manner for analgorithm to control a surgical instrument in response to a particularsensed parameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing, ease of being cut,etc.) and thus respond differently to actions taken by surgicalinstruments. Therefore, it may be desirable for a surgical instrument totake different actions even when the same measurement for a particularparameter is sensed. As one example, the optimal manner in which tocontrol a surgical stapler in response to the surgical stapler sensingan unexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, thesurgical instrument's control algorithm would optimally ramp down themotor in response to an unexpectedly high force to close to avoidtearing the tissue, e.g., change a variable parameter controlling motorspeed or torque so the motor is slower. For tissues that are resistantto tearing, such as stomach tissue, the instrument's algorithm wouldoptimally ramp up the motor in response to an unexpectedly high force toclose to ensure that the end effector is clamped properly on the tissue,e.g., change a variable parameter controlling motor speed or torque sothe motor is faster. Without knowing whether lung or stomach tissue hasbeen clamped, the algorithm may be sub-optimally changed or not changedat all.

A surgical hub can be configured to derive information about a surgicalprocedure being performed based on data received from various datasources and then control modular devices accordingly. In other words,the surgical hub can be configured to infer information about thesurgical procedure from received data and then control the modulardevices operably coupled to the surgical hub based upon the inferredcontext of the surgical procedure. Modular devices can include anysurgical device that is controllable by a situational awareness system,such as visualization system devices (e.g., a camera, a display screen,etc.), smart surgical instruments (e.g., an ultrasonic surgicalinstrument, an electrosurgical instrument, a surgical stapler, smokeevacuators, scopes, etc.). A modular device can include sensor(s)configured to detect parameters associated with a patient with which thedevice is being used and/or associated with the modular device itself.

The contextual information derived or inferred from the received datacan include, for example, a type of surgical procedure being performed,a particular step of the surgical procedure that the surgeon (or othermedical practitioner) is performing, a type of tissue being operated on,or a body cavity that is the subject of the surgical procedure. Thesituational awareness system of the surgical hub can be configured toderive the contextual information from the data received from the datasources in a variety of different ways. In an exemplary embodiment, thecontextual information received by the situational awareness system ofthe surgical hub is associated with a particular control adjustment orset of control adjustments for one or more modular devices. The controladjustments each correspond to a variable parameter. In one example, thesituational awareness system includes a pattern recognition system, ormachine learning system (e.g., an artificial neural network), that hasbeen trained on training data to correlate various inputs (e.g., datafrom databases, patient monitoring devices, and/or modular devices) tocorresponding contextual information regarding a surgical procedure. Inother words, a machine learning system can be trained to accuratelyderive contextual information regarding a surgical procedure from theprovided inputs. In another example, the situational awareness systemcan include a lookup table storing pre-characterized contextualinformation regarding a surgical procedure in association with one ormore inputs (or ranges of inputs) corresponding to the contextualinformation. In response to a query with one or more inputs, the lookuptable can return the corresponding contextual information for thesituational awareness system for controlling at least one modulardevice. In another example, the situational awareness system includes afurther machine learning system, lookup table, or other such system,which generates or retrieves one or more control adjustments for one ormore modular devices when provided the contextual information as input.

A surgical hub including a situational awareness system may provide anynumber of benefits for a surgical system. One benefit includes improvingthe interpretation of sensed and collected data, which would in turnimprove the processing accuracy and/or the usage of the data during thecourse of a surgical procedure. Another benefit is that the situationalawareness system for the surgical hub may improve surgical procedureoutcomes by allowing for adjustment of surgical instruments (and othermodular devices) for the particular context of each surgical procedure(such as adjusting to different tissue types) and validating actionsduring a surgical procedure. Yet another benefit is that the situationalawareness system may improve surgeon's and/or other medicalpractitioners' efficiency in performing surgical procedures byautomatically suggesting next steps, providing data, and adjustingdisplays and other modular devices in the surgical theater according tothe specific context of the procedure. Another benefit includesproactively and automatically controlling modular devices according tothe particular step of the surgical procedure that is being performed toreduce the number of times that medical practitioners are required tointeract with or control the surgical system during the course of asurgical procedure, such as by a situationally aware surgical hubproactively activating a generator to which an RF electrosurgicalinstrument is connected if it determines that a subsequent step of theprocedure requires the use of the instrument. Proactively activating theenergy source allows the instrument to be ready for use a soon as thepreceding step of the procedure is completed.

For example, a situationally aware surgical hub can be configured todetermine what type of tissue is being operated on. Therefore, when anunexpectedly high force to close a surgical instrument's end effector isdetected, the situationally aware surgical hub can be configured tocorrectly ramp up or ramp down a motor of the surgical instrument forthe type of tissue, e.g., by changing or causing change of at least onevariable parameter of an algorithm for the surgical instrument regardingmotor speed or torque.

For another example, a type of tissue being operated can affectadjustments that are made to compression rate and load thresholds of asurgical stapler for a particular tissue gap measurement. Asituationally aware surgical hub can be configured to infer whether asurgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub to determine whether the tissueclamped by an end effector of the surgical stapler is lung tissue (for athoracic procedure) or stomach tissue (for an abdominal procedure). Thesurgical hub can then be configured to cause adjustment of thecompression rate and load thresholds of the surgical staplerappropriately for the type of tissue, e.g., by changing or causingchange of at least one variable parameter of an algorithm for thesurgical stapler regarding compression rate and load threshold.

As yet another example, a type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub can be configured to determinewhether the surgical site is under pressure (by determining that thesurgical procedure is utilizing insufflation) and determine theprocedure type. As a procedure type is generally performed in a specificbody cavity, the surgical hub can be configured to control a motor rateof the smoke evacuator appropriately for the body cavity being operatedin, e.g., by changing or causing change of at least one variableparameter of an algorithm for the smoke evacuator regarding motor rate.Thus, a situationally aware surgical hub may provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, a type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because an endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub canbe configured to determine whether the surgical procedure is anarthroscopic procedure. The surgical hub can be configured to adjust anRF power level or an ultrasonic amplitude of the generator (e.g., adjustenergy level) to compensate for the fluid filled environment, e.g., bychanging or causing change of at least one variable parameter of analgorithm for the instrument and/or a generator regarding energy level.Relatedly, a type of tissue being operated on can affect the optimalenergy level for an ultrasonic surgical instrument or RF electrosurgicalinstrument to operate at. A situationally aware surgical hub can beconfigured to determine what type of surgical procedure is beingperformed and then customize the energy level for the ultrasonicsurgical instrument or RF electrosurgical instrument, respectively,according to the expected tissue profile for the surgical procedure,e.g., by changing or causing change of at least one variable parameterof an algorithm for the instrument and/or a generator regarding energylevel. Furthermore, a situationally aware surgical hub can be configuredto adjust the energy level for the ultrasonic surgical instrument or RFelectrosurgical instrument throughout the course of a surgicalprocedure, rather than just on a procedure-by-procedure basis. Asituationally aware surgical hub can be configured to determine whatstep of the surgical procedure is being performed or will subsequentlybe performed and then update the control algorithm(s) for the generatorand/or ultrasonic surgical instrument or RF electrosurgical instrumentto set the energy level at a value appropriate for the expected tissuetype according to the surgical procedure step.

As another example, a situationally aware surgical hub can be configuredto determine whether the current or subsequent step of a surgicalprocedure requires a different view or degree of magnification on adisplay according to feature(s) at the surgical site that the surgeonand/or other medical practitioner is expected to need to view. Thesurgical hub can be configured to proactively change the displayed view(supplied by, e.g., an imaging device for a visualization system)accordingly so that the display automatically adjusts throughout thesurgical procedure.

As yet another example, a situationally aware surgical hub can beconfigured to determine which step of a surgical procedure is beingperformed or will subsequently be performed and whether particular dataor comparisons between data will be required for that step of thesurgical procedure. The surgical hub can be configured to automaticallycall up data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon or other medical practitionerto ask for the particular information.

As another example, a situationally aware surgical hub can be configuredto determine whether a surgeon and/or other medical practitioner ismaking an error or otherwise deviating from an expected course of actionduring the course of a surgical procedure, e.g., as provided in apre-operative surgical plan. For example, the surgical hub can beconfigured to determine a type of surgical procedure being performed,retrieve a corresponding list of steps or order of equipment usage(e.g., from a memory), and then compare the steps being performed or theequipment being used during the course of the surgical procedure to theexpected steps or equipment for the type of surgical procedure that thesurgical hub determined is being performed. The surgical hub can beconfigured to provide an alert (visual, audible, and/or tactile)indicating that an unexpected action is being performed or an unexpecteddevice is being utilized at the particular step in the surgicalprocedure.

In certain instances, operation of a robotic surgical system, such asany of the various robotic surgical systems described herein, can becontrolled by the surgical hub based on its situational awareness and/orfeedback from the components thereof and/or based on information from acloud (e.g., the cloud 713 of FIG. 18 ).

Embodiments of situational awareness systems and using situationalawareness systems during performance of a surgical procedure aredescribed further in previously mentioned U.S. patent application Ser.No. 16/729,772 entitled “Analyzing Surgical Trends By A Surgical System”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,747entitled “Dynamic Surgical Visualization Systems” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,744 entitled “VisualizationSystems Using Structured Light” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,778 entitled “System And Method ForDetermining, Adjusting, And Managing Resection Margin About A SubjectTissue” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,729entitled “Surgical Systems For Proposing And Corroborating Organ PortionRemovals” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,778 entitled “Surgical System For Overlaying Surgical InstrumentData Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,751 entitled “SurgicalSystems For Generating Three Dimensional Constructs Of Anatomical OrgansAnd Coupling Identified Anatomical Structures Thereto” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,740 entitled “SurgicalSystems Correlating Visualization Data And Powered Surgical InstrumentData” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,737entitled “Adaptive Surgical System Control According To Surgical SmokeCloud Characteristics” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, and U.S. patent applicationSer. No. 16/729,807 entitled “Method Of Using Imaging Devices InSurgery” filed Dec. 30, 2019.

Surgical Procedures of the Lung

Various aspects of the devices, systems, and methods described hereinmay relate to a surgical procedure performed on a lung. For example, alung resection, e.g., a lobectomy, is a surgical procedure in which allor part, e.g., one or more lobes, of a lung is removed. The purpose ofperforming a lung resection is to treat a damaged or diseased lung as aresult of, for example, lung cancer, emphysema, or bronchiectasis.

During a lung resection, the lung or lungs are first deflated, andthereafter one or more incisions are made on the patient's side betweenthe patient's ribs to reach the lungs laparoscopically. Surgicalinstruments, such as graspers and a laparoscope, are inserted throughthe incision. Once the infected or damaged area of the lung isidentified, the area is dissected from the lung and removed from the oneor more incisions. The dissected area and the one or more incisions canbe closed, for example, with a surgical stapler or stitches.

Since the lung is deflated during surgery, the lung, or certain portionsthereof, may need to be mobilized to allow the surgical instruments toreach the surgical site. This mobilization can be carried out bygrasping the outer tissue layer of the lung with graspers and applying aforce to the lung through the graspers. However, the pleura andparenchyma of the lung are very fragile and therefore can be easilyripped or torn under the applied force. Additionally, duringmobilization, the graspers can cut off blood supply to one or more areasof the lung.

Further, a breathing tube is placed into the patient's airway to alloweach lung to be separately inflated during surgery. Inflation of thelung can cause the lung to move and match pre-operative imaging and/orallow the surgeon to check for leaks at the dissected area(s). However,by inflating the whole lung, working space is lost around the lung dueto the filling of the thoracic cavity. Additionally, inflating a wholelung can take time and does not guarantee easy leak detection ifmultiple portions of the lung are operated on during the surgicalprocedure.

Surgical Procedures of the Colon

Various aspects of the devices, systems, and methods described hereinmay relate to a surgical procedure performed on a colon. For example,surgery is often the main treatment for early-stage colon cancers. Thetype of surgery used depends on the stage (extent) of the cancer, whereit is in the colon, and the goal of the surgery. Some early coloncancers (stage 0 and some early stage I tumors) and most polyps can beremoved during a colonoscopy. However, if the cancer has progressed, alocal excision or colectomy may be required. A colectomy is surgery toremove all or part of the colon. In certain instances, nearby lymphnodes are also removed. If only part of the colon is removed, it'scalled a hemicolectomy, partial colectomy, or segmental resection inwhich the surgeon takes out the diseased part of the colon with a smallsegment of non-diseased colon on either side. Usually, about one-fourthto one-third of the colon is removed, depending on the size and locationof the cancer. Major resections of the colon are illustrated in FIG. 22, in which A-B is a right hemicolectomy, A-C is an extended righthemicolectomy, B-C is a transverse colectomy, C-E is a lefthemicolectomy, D-E is a sigmoid colectomy, D-F is an anterior resection,D-G is a (ultra) low anterior resection, D-H is an abdomino-perinealresection, A-D is a subtotal colectomy, A-E is a total colectomy, andA-H is a total procto-colectomy. Once the resection is complete, theremaining intact sections of colon are then reattached.

A colectomy can be performed through an open colectomy, where a singleincision through the abdominal wall is used to access the colon forseparation and removal of the affected colon tissue, and through alaparoscopic-assisted colectomy. With a laparoscopic-assisted colectomy,the surgery is done through many smaller incisions with surgicalinstruments and a laparoscope passing through the small incisions toremove the entire colon or a part thereof. At the beginning of theprocedure, the abdomen is inflated with gas, e.g., carbon dioxide, toprovide a working space for the surgeon. The laparoscope transmitsimages inside the abdominal cavity, giving the surgeon a magnified viewof the patient's internal organs on a monitor or other display. Severalother cannulas are inserted to allow the surgeon to work inside andremove part(s) of the colon. Once the diseased parts of the colon areremoved, the remaining ends of the colon are attached to each other,e.g., via staplers or stitches. The entire procedure may be completedthrough the cannulas or by lengthening one of the small cannulaincisions.

During a laparoscopic-assisted colectomy procedure, it is oftendifficult to obtain an adequate operative field. Oftentimes, dissectionsare made deep in the pelvis which makes it difficult to obtain adequatevisualization of the area. As a result, the lower rectum must be liftedand rotated to gain access to the veins and arteries around both sidesof the rectum during mobilization. During manipulation of the lowerrectum, bunching of tissue and/or overstretching of tissue can occur.Additionally, a tumor within the rectum can cause adhesions in thesurrounding pelvis, and as a result, this can require freeing the rectalstump and mobilizing the mesentery and blood supply before transectionand removal of the tumor.

Further, multiple graspers are needed to position the tumor for removalfrom the colon. During dissection of the colon, the tumor should beplaced under tension, which requires grasping and stretching thesurrounding healthy tissue of the colon. However, the manipulating ofthe tissue surrounding the tumor can suffer from reduced blood flow andtrauma due to the graspers placing a high grip force on the tissue.Additionally, during a colectomy, the transverse colon and upperdescending colon may need to be mobilized to allow the healthy, goodremaining colon to be brought down to connect to the rectal stump afterthe section of the colon containing the tumor is transected and removed.

After a colectomy, the remaining healthy portions of the colon must bereattached to one another to create a path for waste to leave the body.However, when using laparoscopic instruments to perform the colectomy,one single entry port may not have a large enough range of motion tomove the one end of the colon to a connecting portion of the colon. Assuch, a second entry port is therefore needed to laparoscopically insertsurgical instruments to help mobilize the colon in order to properlyposition the colon.

Surgical Procedures of the Stomach

Various aspects of the devices, systems, and methods described hereinmay relate to a surgical procedure performed on a stomach. For example,surgery is the most common treatment for stomach cancer. When surgery isrequired for stomach cancer, the goal is to remove the entire tumor aswell as a good margin of healthy stomach tissue around the tumor.Different procedures can be used to remove stomach cancer. The type ofprocedure used depends on what part of the stomach the cancer is locatedand how far it has grown into nearby areas. For example, endoscopicmucosal resection (EMR) and endoscopic submucosal dissection (ESD) areprocedures on the stomach can be used to treat some early-stage cancers.These procedures do not require a cut in the skin, but instead thesurgeon passes an endoscope down the throat and into the stomach of thepatient. Surgical tools (e.g., MEGADYNE™ Tissue Dissector orElectrosurgical Pencils) are then passed through the working channel ofthe endoscope to remove the tumor and some layers of the normal stomachwall below and around it.

Other surgical procedures performed on a stomach include a subtotal(partial) or a total gastrectomy that can be performed as an openprocedure. e.g., surgical instruments are inserted through a largeincision in the skin of the abdomen, or as a laparoscopic procedure,e.g., surgical instruments are inserted into the abdomen through severalsmall cuts. For example, a laparoscopic gastrectomy procedure generallyinvolves insufflation of the abdominal cavity with carbon dioxide gas toa pressure of around 15 millimeters of mercury (mm Hg). The abdominalwall is pierced and a straight tubular cannula or trocar, such as acannula or trocar having a diameter in a range of about 5 mm to about 10mm, is then inserted into the abdominal cavity. A laparoscope connectedto an operating room monitor is used to visualize the operative fieldand is placed through one of the trocar(s). Laparoscopic surgicalinstruments are placed through two or more additional cannulas ortrocars for manipulation by medical practitioner(s), e.g., surgeon andsurgical assistant(s), to remove the desired portion(s) of the stomach.

In certain instances, laparoscopic and endoscopic cooperative surgerycan be used to remove gastric tumors. This cooperative surgery typicallyinvolves introduction of an endoscope, e.g., a gastroscope, andlaparoscopic trocars. A laparoscope and tissue manipulation anddissection surgical instruments are introduced through the trocar. Thetumor location can be identified via the endoscope and a cutting elementthat is inserted into the working channel of the endoscope is then usedfor submucosal resection around the tumor. A laparoscopic dissectionsurgical instrument is then used for seromuscular dissection adjacentthe tumor margins to create an incision through the stomach wall. Thetumor is then pivoted through this incision from the intraluminal space,e.g., inside the stomach, to the extraluminal space, e.g., outside ofthe stomach. A laparoscopic surgical instrument, e.g., an endocutter,can be used to then complete the transection of the tumor from thestomach wall and seal the incision.

Surgical Procedures of the Intestine

Various aspects of the devices, systems, and methods described hereinmay relate to a surgical procedure performed on an intestine. Forexample, a duodenal mucosal resurfacing (DMR) procedure can be performedendoscopically to treat insulin-resistant metabolic diseases such astype 2 diabetes. The DMR procedure can be an effective treatment becauseit affects detection of food. The DMR procedure inhibits duodenumfunction such that food tends to be sensed deeper in the intestine thannormal, e.g., sensed after passage through the duodenum (which is thefirst part of the small intestine). The patient's body thus senses sugardeeper in the intestine than is typical and thus reacts to the sugarlater than is typical such that glycemic control can be improved. Theirregular function of the duodenum changes the body's typical responseto the food and, through nervous system and chemical signals, causes thebody to adapt its response to the glucose level to increase insulinlevels.

In the DMR procedure, the duodenal mucosa is lifted, such as withsaline, and then the mucosa is ablated, e.g., using an ablation deviceadvanced into the duodenum through a working channel of an endoscope.Lifting the mucosa before ablation helps protect the duodenum's outerlayers from being damaged by the ablation. After the mucosa is ablated,the mucosa later regenerates. Examples of ablation devices are NeuWave™ablation probes (available from Ethicon US LLC of Cincinnati, Ohio).Another example of an ablation device is the Hyblate catheter ablationprobe (available from Hyblate Medical of Misgav, Israel). Anotherexample of an ablation device is the Barxx™ HaloFlex (available fromMedtronic of Minneapolis, Minn.).

FIG. 22A illustrates one embodiment of a DMR procedure. As shown in FIG.22A, a laparoscope 1400 is positioned external to a duodenum 1402 forexternal visualization of the duodenum 1402. An endoscope 1404 isadvanced transorally through an esophagus 1406, through a stomach 1408,and into the duodenum 1402 for internal visualization of the duodenum1402. An ablation device 1410 is advanced through a working channel ofthe endoscope 1404 to extend distally from the endoscope 1404 into theduodenum 1402. A balloon 1412 of the ablation device 1410 is shownexpanded or inflated in FIG. 22A. The expanded or inflated balloon 1412can help center the ablation device's electrode so even circumferentialablating can occur before the ablation device 1410 is advanced and/orretracted to repeat ablation. Before the mucosa is ablated using theablation device 1410, the duodenal mucosa is lifted, such as withsaline. In some embodiments in addition to or instead of including theballoon 1412, the ablation device 1410 can be expandable/collapsibleusing an electrode array or basket configured to expand and collapse.

The laparoscope's external visualization of the duodenum 1402 can allowfor thermal monitoring of the duodenum 1402, which may help ensure thatthe outer layers of the duodenum 1402 are not damaged by the ablation ofthe duodenal mucosa, such as by the duodenum being perforated. Variousembodiments of thermal monitoring are discussed further, for example,below and in U.S. patent application Ser. No. 17/494,364 entitled“Surgical Methods For Control Of One Visualization With Another” filedon Oct. 5, 2021. The endoscope 1404 and/or the ablation device 1410 caninclude a fiducial marker thereon that the laparoscope 1400 can beconfigured to visualize through the duodenum's tissue, e.g., by usinginvisible light, to help determine where the laparoscope 1400 shouldexternally visualize the duodenum 1402 at a location where ablationoccurs. Various embodiments of fiducial markers are discussed further,for example, in U.S. patent application Ser. No. 17/493,913 entitled“Surgical Methods Using Fiducial Identification And Tracking” filed onOct. 5, 2021 and in U.S. patent application Ser. No. 17/494,364 entitled“Surgical Methods For Control Of One Visualization With Another” filedon Oct. 5, 2021.

Controlling Power

Devices, systems, and methods for multi-source imaging provided hereinmay allow for controlling power. In general, controlling power canprevent an ablation device from applying too much power to tissue via anelectrode of the ablation device, which can result in inadvertentcollateral damage such as tissue wall perforation. The power output byan ablation device can be monitored, thereby allowing for the powercontrol. Examples of ablation devices are NeuWave™ ablation probes(available from Ethicon US LLC of Cincinnati, Ohio). Another example ofan ablation device is the Hyblate catheter ablation probe (availablefrom Hyblate Medical of Misgav, Israel). Another example of an ablationdevice is the Barxx™ HaloFlex (available from Medtronic of Minneapolis,Minn.). Other examples of ablation devices are discussed further in, forexample, U.S. patent application Ser. No. 17/494,364 entitled “SurgicalMethods For Control Of One Visualization With Another” filed on Oct. 5,2021.

After a laparoscopic portion of a segmentectomy (segment resection) hasbeen completed, an ablation device can be advanced through a workingchannel of a flexible endoscope and used to ablate a tumor or othertarget tissue. The ablation device can be a radiofrequency (RF) cauterytool or a microwave ablation tool. Ablation devices can be used toablate tissue in other types of surgical procedures as well.

The energy (power) of an ablation device can be controlled byvisualizing thermal or therapeutic effects from an opposite side of atissue wall from where the ablation device is applying the energy. FIG.23 illustrates one embodiment in which the energy (power) of a microwaveablation device (probe) 1280 can be controlled by visualizing thermal ortherapeutic effects from an opposite side of a tissue wall 1282, e.g.,using an infrared (IR) thermal camera 1284 positioned outside the tissuewall 1282, from where the ablation device 1280 is applying the energy toa tumor 1286. The tissue wall 1282 is a lung wall in this illustratedembodiment, but thermal or therapeutic effects can be similarlyvisualized and used in controlling power in surgical proceduresperformed elsewhere, such as in a duodenal mucosal resurfacing procedurein which duodenal mucosa is ablated. Infrared images 1288 gathered bythe IR thermal camera at four times t₀, t₂, t₄, t₆ are shown in FIG. 23.

FIG. 23 also shows a graph indicating each of IR camera 1284 temperature(° C.), ablation probe 1280 position (cm), and ablation probe 1280 powerlevel (W) versus time. As indicated in the graph, the IR thermal camera1284 monitors the temperature of the ablation device's ablation zone(e.g., an area of ablation that an ablation device 1280 can create),which includes the tumor 1286 and a margin area around the tumor 1286within the ablation zone. The times in the graph include the four timest₀, t₂, t₄, t₆ for which IR images are shown.

The therapeutic temperature range for tissue ablation is in a range fromabout 60° C. to about 100° C. As shown in the graph, the power level iscontrolled so the tumor 1286 is being ablated within the therapeutictemperature range from a time between times t₁ and t₂ to when energyapplication stops shortly before time t₆ between times t₅ and t₆. Thetemperature decreases from time t₂ and t₃, so the power level isincreased at time t₃ to prevent the temperature from falling below about60° C. The temperature increases from time t₃ and t₄, so the power levelis decreased at time t₄ to prevent the temperature from rising aboveabout 100° C. The temperature decreases again shortly before time t₅, sothe power level is increased at time t₅ to prevent the temperature fromfalling below about 60° C.

Tissue being at a temperature up to about 41° C. can cause blood vesseldilation and increased blood perfusion and trigger a heat-shock responsebut have little long term effect. The tissue being at a temperatureabove about 41° C. makes the tissue susceptible to or causes the tissueto incur irreversible cell damage, with the higher the temperaturecorresponding to more damage. As shown in the graph, the power level isalso controlled so the temperature of the healthy, non-target lungtissue in the ablation zone is kept below about 41° C. for as long aspossible while maintaining effective ablation of the tumor 1286.

For yet another example, an ablation device can include a plurality ofelectrodes that are equally spaced about a center of the device. Theplurality of electrodes are configured to move between a compressedconfiguration, which facilitates movement of the ablation device intoand out of a patient, and an expanded configuration, which facilitatesenergy application to tissue by the electrodes that each contacts thetissue. Each of the electrodes is segmented and is configured to takeinitial impedance and temperature readings. One embodiment of such anablation device 1290 is shown in FIG. 24 , FIG. 25 , and FIG. 26 . FIG.24 shows the ablation device 1290 in a compressed configuration in whichthe ablation device's electrodes extend linearly. FIG. 25 and FIG. 26show the ablation device 1290 in an expanded configuration in which theelectrodes are radially expanded. FIG. 26 also shows the ablation device1290 advanced into position relative to a tumor 1292 through anendoscope 1294, with the electrodes advanced distally out of theablation device's sheath 1290. The distal advancement of the electrodesout of the sheath 1296 (or proximal movement of the sheath 1296 relativeto the electrodes) causes the electrodes to automatically radiallyexpand. Correspondingly, proximal movement of the electrodes into thesheath 1296 (or distal movement of the sheath 1296 relative to theelectrodes) causes the electrodes to automatically radially contract. Insome embodiments, the sheath 1296 may be omitted such that movement ofthe electrodes into and out of the endoscope 1294 causes expansion andcompression of the electrodes.

To facilitate power control, each of the electrodes can contact tissueon one side of a tissue wall. A camera, e.g., the IR thermal camera 1284of FIG. 23 , can be positioned on an opposite side of the tissue wall.The electrodes can then begin applying a low level of power to thetissue. These low level energy pulses can be used to align the camera tothe precise area to be internally heated. The ablation device 1290 canshare the electrodes' initial impedance and temperature readings, whichcan serve as a baseline. The electrodes can then begin applyingtherapeutic energy, with the power being controlled based on the thermalenergy measured by the camera as discussed above, such as by adjustingat least one variable parameter of a control algorithm. Such an approachcan be used in a bipolar or a monopolar configuration. Introducingsaline between the mucosa and submucosa may help control the tissueheating to just the mucosa and to more specific depths by impedancemonitoring. The ablation device 1290 can be rotated clockwise orcounterclockwise such that the electrodes correspondingly rotateclockwise or counterclockwise, which may provide higher current densityin the event that additional heating is required, such as if the tissueis not being heated to the therapeutic ablation temperature range.

Color of tissue adjacent to tissue being ablated can be monitored andused to control power. The color of tissue can be used to indicateeither the heal of the tissue or the tissue's vascularization capacity.In general, a color change over time can indicate that ablation energylevel should be adjusted.

FIG. 27 illustrates one embodiment in which tissue color can be used tocontrol power. A flexible scope 1295 has been advanced into a body lumen1296. An ablation device 1297 has been advanced through a workingchannel of the scope 1295 to extend distally beyond the scope 1295 suchthat an expandable member 1297 f of the ablation device 1297 hasexpanded radially. A laparoscope 1298 has been positioned outside thelumen 1296 so as to be positioned on an opposite side of a tissue wall1296 w (defined by the lumen 1296) than the scope 1295 and the ablationdevice 1297. A field of view 1298 v is shown for the laparoscope 1298.Before the ablation device 1297 begins applying energy to the tissue viaan electrode (which can be one or more electrodes) of the ablationdevice 1297, the laparoscope 1298 establishes an average color scale fortissue within its field of view 1298 w, within which energy will beapplied on the other side of the tissue wall 1296 w. Thereafter, asenergy is applied to the tissue via the electrode and the tissue iscooked from the inside, the tissue will tend to change color by becominglighter. For example, the average color scale of tissue can be a pinkishred, and the energy application can cause the tissue to lighten to alighter pinkish red or to a whitish shade. As the tissue changes colorduring energy application, and the laparoscope 1298 continues to monitorthe tissue color, the laparoscope 1298 can trigger the energy level tochange, e.g., providing a signal to a surgical hub, robotic surgicalsystem, or other computer system also in communication with the ablationdevice 1297 that triggers a change in at least one variable parameter,in response to the color reaching a predetermined light shade. There maybe a plurality of predetermined light shades, each corresponding to adifferent energy control change. The change in energy level may bemoving to an energy level of zero so as to stop energy delivery, as thetissue color change may indicate that the tissue is being coagulatedsuch that energy application should be stopped. Additionally, bubbling,effects of escaping steam, or effects of higher temperature fluids onadjacent tissue(s) can be monitored, either directly or by monitoringthe effects on the adjacent tissue(s).

In some embodiments in which tissue is ablated, a flexible force probecan be used to help keep a consistent thickness of tissue, which mayhelp ensure that the tissue eventually ablated has a consistentthickness. Consistent thickness generally helps ensure consistentheating of the tissue. FIG. 28 and FIG. 29 illustrate one embodiment ofa flexible force probe 1293 configured to apply force to a tissue wall1291 from one side of the tissue wall 1291, which in this illustratedembodiment is outside of a body lumen 1289 in which a scope 1287 ispositioned. The lumen 1289 is not shown in FIG. 29 . The flexible forceprobe 1293 includes an arm 1293 a configured to abut and press againstthe tissue wall 1291. The arm 1293 a can be flexible to allow the arm1293 a to conform to the shape of the tissue wall 1291. With the scope1287 positioned on the opposite side of the tissue wall 1291 while thearm 1293 a is pressing against the tissue wall 1291, a thickness 1291 tof the tissue wall 1291 can be controlled to a consistent thickness.Since the internal path of the scope 1287 is known within the lumen1289, the probe 1293 external to the lumen 1289 can follow the samespline path with the arm 1293 a pressing on the tissue wall 1291 tocontrol the tissue thickness 1291 t.

In some embodiments in which tissue is ablated using an ablation device,visualization can be used to monitor either collateral effects of theablation device's energy application or the active intentional use ofthe ablation device near critical structure(s). The monitoring may helpprevent inadvertent damage. The monitoring can include monitoring alocation of the ablation device and data communicated from the ablationdevice indicating that the ablation device is active (e.g., is applyingenergy), monitoring tissue temperature, monitoring color of ejectedsteam, and/or monitoring effects caused by the ablation device. Themonitoring can serve a means to compare the ablation device's affectedablation zone to surrounding critical structure(s) location andsensitivity. For example, multi-spectral imaging can be used to detect aureter in proximity to a location where the ablation device is applyingenergy and to trigger the ablating to stop if the ablation zone becomeswithin a threshold distance of the ureter.

Devices and systems disclosed herein can be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the devices can be reconditioned for reuseafter at least one use. Reconditioning can include any combination ofthe steps of disassembly of the devices, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, the devices can be disassembled, and any number of theparticular pieces or parts of the device can be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, the devices can be reassembled for subsequent useeither at a reconditioning facility, or by a surgical team immediatelyprior to a surgical procedure. Those skilled in the art will appreciatethat reconditioning of a device can utilize a variety of techniques fordisassembly, cleaning/replacement, and reassembly. Use of suchtechniques, and the resulting reconditioned device, are all within thescope of the present application.

It can be preferred that devices disclosed herein be sterilized beforeuse. This can be done by any number of ways known to those skilled inthe art including beta or gamma radiation, ethylene oxide, steam, and aliquid bath (e.g., cold soak). An exemplary embodiment of sterilizing adevice including internal circuitry is described in more detail in U.S.Pat. No. 8,114,345 issued Feb. 14, 2012 and entitled “System And MethodOf Sterilizing An Implantable Medical Device.” It is preferred thatdevice, if implanted, is hermetically sealed. This can be done by anynumber of ways known to those skilled in the art.

The present disclosure has been described above by way of example onlywithin the context of the overall disclosure provided herein. It will beappreciated that modifications within the spirit and scope of the claimsmay be made without departing from the overall scope of the presentdisclosure. All publications and references cited herein are expresslyincorporated herein by reference in their entirety for all purposes.

What is claimed is:
 1. A surgical system, comprising: a firstvisualization system configured to visualize a surgical site; a surgicalinstrument configured to be advanced to the surgical site through alumen of the first visualization system, and the surgical including anelectrode configured to deliver energy to tissue at a surgical site; asecond visualization system configured to visualize the surgical site;and a controller configured to be operatively coupled to theelectrosurgical instrument and to the second visualization system,monitor the electrode's energy delivery to the tissue during thedelivery and during the second visualization system's visualization ofthe surgical site, and control energizing of the electrode such that aparameter associated with the tissue does not exceed a predefinedmaximum threshold.
 2. The system of claim 1, wherein the predefinedmaximum threshold includes a temperature of the tissue; and the systemfurther comprises a sensor operatively coupled to the controller andconfigured to measure the temperature of the tissue.
 3. The system ofclaim 1, wherein the predefined maximum threshold includes a temperatureof the tissue; and the electrode includes an electrode array configuredto measure the temperature of the tissue.
 4. The system of claim 1,wherein the predefined maximum threshold includes a surface watercontent of the tissue; and the system further comprises a sensoroperatively coupled to the controller and configured to measure thesurface water content of the tissue.
 5. The system of claim 1, whereinthe predefined maximum threshold includes a refractivity of the tissue;and at least one of the first and second visualization systems isconfigured to measure the refractivity of the tissue.
 6. The system ofclaim 1, wherein the first visualization system is configured tovisualize within a hollow organ at the surgical site; the tissue istissue within the hollow organ; and the second visualization system isconfigured to visualize outside the hollow organ.
 7. The system of claim1, wherein the energy includes one of radiofrequency (RF) energy andmicrowave energy.
 8. The system of claim 1, wherein the tissue includesa tumor; and the energy includes cold so as to treat the tumor withcyroablation.
 9. The system of claim 1, wherein a surgical hub includesthe controller.
 10. The system of claim 1, wherein a robotic surgicalsystem includes the controller; and the surgical instrument isconfigured to be releasably coupled to and controlled by the roboticsurgical system.
 11. A surgical method, comprising: visualizing asurgical site with a first visualization system; visualizing thesurgical site with a second visualization system configured to visualizethe surgical site; monitoring, with a controller and during the secondvisualization system's visualization of the surgical site, energydelivery to tissue at the surgical site, the energy being delivered tothe tissue by an electrode of a surgical instrument positioned in alumen of the first visualization system; and controlling, with thecontroller, energizing of the electrode such that a parameter associatedwith the tissue does not exceed a predefined maximum threshold.
 12. Themethod of claim 11, wherein the predefined maximum threshold includes atemperature of the tissue; and the method further comprises measuringthe temperature of the tissue with a sensor operatively coupled to thecontroller.
 13. The method of claim 11, wherein the predefined maximumthreshold includes a temperature of the tissue; the electrode includesan electrode array; and the method further comprises measuring thetemperature of the tissue with the electrode array.
 14. The method ofclaim 11, wherein the predefined maximum threshold includes a surfacewater content of the tissue; and the method further comprises measuringthe surface water content of the tissue with a sensor operativelycoupled to the controller.
 15. The method of claim 11, wherein thepredefined maximum threshold includes a refractivity of the tissue; andthe method further comprises measuring the refractivity of the tissuewith at least one of the first and second visualization systems.
 16. Themethod of claim 11, wherein the first visualization system isvisualizing within a hollow organ at the surgical site; the tissue istissue within the hollow organ; and the second visualization system isvisualizing outside the hollow organ.
 17. The method of claim 11,wherein the energy includes one of radiofrequency (RF) energy andmicrowave energy.
 18. The method of claim 11, wherein the tissueincludes a tumor; and the energy includes cold so as to treat the tumorwith cyroablation.
 19. The method of claim 11, wherein a surgical hubincludes the controller.
 20. The method of claim 11, wherein a roboticsurgical system includes the controller; and the surgical instrument isconfigured to be releasably coupled to and controlled by the roboticsurgical system.